FDA Exerts FSMA Authority - Food Safety

Updated June 24, 2024

The original link broke.

You might also like:

New Era of Smarter Food Safety - FDA.gov

---  the original post follows below  ---

FDA Writing New Chapters in Food Safety History | FDA Voice:

"With the suspension of Sunland’s food facility registration, for the first time FDA was, in effect, able to independently prevent a company from distributing food that could have caused harm to consumers. This was our first use of this new authority granted by the FDA Food Safety Modernization Act (FSMA), and it will be an important tool for FDA to use in the future to ensure the accountability of companies for the safety of the food they produce.

Under the decree, Sunland must hire an independent sanitation expert to develop a program to ensure products are produced in a sanitary way and according to good manufacturing practices. The company must also conduct environmental testing to ensure that disease-causing bacteria aren’t present in its facility or in its final food products. FDA will evaluate the programs Sunland sets up, and will not allow the company to operate its peanut butter plant until we determine that its products can be safely produced. "

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

GMP Master Training Plans - Free Tips (Video)

Watch this video for free tips on GXP, QSR, and GMP Master Training Plans.

 

Return to SkillsPlus International Info Blog - Home

SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

Related articles

• 
  2013 GMP Training - It's Time To Start Planning
• 
  Consider On-Site Training - Popular GMP Classes and QSR Courses
• 
  Why GMP Training Does Seem To Work
• 
  GMP Posters & QSR Posters - Buy The Entire Collection!

Food Safety Regulations Backlog Affects FDA and USDA

Backlog for Food Safety Regulations Includes Both FDA and USDA | Food Safety News:

"Everyone knows about the food safety rules held up by “oh-eye-rah,” or as it is formally known at the White House, the Office of Information and Regulatory Affairs (OIRA). But it’s not just the U.S. Food and Drug Administration (FDA) that is waiting; the U.S. Department of Agriculture (USDA) also has food safety rules on hold too.

OIRA – the executive branch’s regulatory referee – has recently turned into a  bottleneck for the rules FDA needs to implement the new Food Safety Modernization Act.  The Act has been the subject of a lot of attention and, in recent months, even a lawsuit. A USDA rule requiring meat businesses to improve grinding logs and inventories, however, has gone relatively unnoticed, but this law is also held up by the powerful little White House office."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• FDA Increases Winery Inspections (drughealth.blogspot.com)

FDA Public Hearing on Antiseptic Patient Preoperative Skin Preparation Products

• Trusted FDA GMP online training programs, courses, and classes offered by SkillsPlus International Inc.

Updated October 12, 2022

The original link broke.

You can still read about the same topic here:

Safety and Effectiveness for Health Care Antiseptics; TopicalAntimicrobial Drug Products for Over-the-Counter HumanUse; Proposed Amendment of the Tentative Final Monograph;Reopening of Administrative Record - FDA.gov (PDF)  

- - -  the original post follows below  - - -

News & Events > Antiseptic Patient Preoperative Skin Preparation Products:

"The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products. Currently, patient preoperative skin preparations are not required to be sterile, and bacteria can contaminate these products at the time of manufacture or during product use. Contaminated patient preoperative skin preparations have been associated with clinical infections and adverse outcomes. At this public hearing, FDA is interested in obtaining public comment about certain scientific and product use issues related to patient preoperative skin preparations"

'via Blog this'

Meeting Details:

Date(s):      December 12 - 13, 2012

Time:           9:00 a.m. to 4:00 p.m.

Location:     DoubleTree by Hilton Hotel Washington DC/Silver Spring
                      The Ballrooms
                      8727 Colesville Road
                      Silver Spring, MD 20910

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

What You Should Know for the upcoming Flu Season - from the CDC

Updated May 7, 2019

The links below broke.

You might also be interested in:
Influenza (Flu) - CDC:  Learn about the current flu season & treatments, and more!


- - -  original post follows below  - - -

Follow the link below to checkout the CDC's very comprehensive Q & A webpage. Lots of answers to just about every question you might ask.

CDC - Seasonal Influenza (Flu) - What You Should Know for the 2012-2013 Influenza Season:
 'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

FDA Increases Winery Inspections

FDA Takes a Growing Interest in Winery Safety | News | News & Features | Wine Spectator:

"While winery inspections are not new, they’re being ramped up under the 2011 Food Safety Modernization Act, according to FDA spokeswoman Patricia El-Hinnawy.

The federal law mandates that the FDA inspect all food processing establishments. The frequency of inspections is based on safety risk and compliance history. While wineries are considered low risk because the fermentation process kills pathogens, all food facilities must be inspected within seven years and at least once every five years after that. “The FDA may be conducting more inspections [at wineries] than it has done in the recent past, in order to meet the [law’s] requirements,” El-Hinnawy said."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA on the Ranbaxy Atorvastatin Recall

• Trusted FDA CGMP online training courses and programs offered by SkillsPlus International Inc.

The FDA is providing additional related information. Just follow the link below.

Drug Safety and Availability > FDA Statement on the Ranbaxy Atorvastatin Recall:

"FDA Statement on the Ranbaxy Atorvastatin Recall

Update: 11/30/2012
FDA is notifying the public that after reviewing additional information related to the Ranbaxy atorvastatin recall, FDA has determined that the possibility of adverse health problems related to the recalled atorvastatin is extremely low.

What patients should know . . . "

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

World AIDS Day - FDA Voice

• Respected FDA CGMP online training courses and programs taught by SkillsPlus International Inc.

Updated February 15, 2022

The original link broke.

You can still read about the same topic here:

World AIDS Day - CDC.gov

---  the original post follows below  ---

World AIDS Day | FDA Voice:

"The Food and Drug Administration supports the fight against HIV/AIDS by promoting medical innovation, protecting the blood supply, and reviewing and regulating new and existing medical products, including devices used in prevention, such as condoms and medical gloves. Doctors, nurses, pharmacists, scientists and many others at FDA have worked hard in 2012 to make sure that there are safe and effective medical products and devices available to fight HIV/AIDS."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

More fake drugs now using active ingredients

SecuringIndustry.com - Many more fake drugs now using real APIs, US official says:

"The US Department of Commerce reports that more and more counterfeit pharmaceuticals are using real APIs to trick patients.

Globalisation of the active pharmaceutical ingredient (API) supply chain means raw materials are more readily available in countries where counterfeit manufacturing takes place.

The trend has helped counterfeiters change the composition of their products, Security Management reports.

"Twenty years ago most counterfeit medicines did not contain any medicinal ingredients. They had ground up dry wall, sawdust, anything to make the product look real," said Jeffrey Gren, director, Office of Health and Consumer Goods at the US Department of Commerce, said."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training - for Pharma & Biotech
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA and Supplement Regulations

Updated 11/7/2015:

You might have been looking for these:

Death By Dietary Supplement (Forbes) - Lamar Odom, etc.

USP launches new GMP audit certification program

By Stephen DANIELLS, 03-Nov-2015
There’s a new player in the GMP audit sector, with the United States Pharmacopeial Convention (USP) expanding its verification services to include a new GMP audit program for dietary supplement and dietary ingredient manufacturers.

= = = original post below = = =

This Slate article is an interesting read about the proliferation of dietary supplements, and the interest in tighter regulatory oversight.

Herbal supplement dangers: FDA does not regulate supplements and they can be deadly. - Slate Magazine:

"Between 1994 and 2008, the number of dietary supplement products on the market increased from 4,000 to 75,000. In the first 10 months of 2008, the FDA received nearly 600 reports of serious adverse events (including hospitalization, disability, and death) from these products and 350 reports of moderate or mild adverse events. However, the FDA believes that these reports are drastically underreported and estimates that the annual number of all adverse events is 50,000."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Closes Down Another Dietary Supplement Company

Updated September 17, 2024

You might also be interested in:

Dietary Supplements - FDA

---  the original post follows below  ---

Another dietary supplement company, PUH, closed down by FDA:

"Pharmacist’s Ultimate Health of St. Paul, Minnesota agreed to a consent decree to cease their unlawful distribution of unapproved new drugs and adulterated dietary supplements. They have to stop distributing their products until all disease claims are removed from their websites and product labels and they comply with cGMP requirements for dietary supplements.

The company marketed products capsules, topical creams, and botanical extracts under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy. The product names include Allergy Relief Complex, Lycopene Standardized Extract, Co Q-10, Cold and Flu Defense, Cholesterol Homocysteine, Prostate Companion, Ginger Root Standardized Extract, and Progesterone Cream, among others."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Ranbaxy Generic Lipitor Recalled

Generic Lipitor Recalled - Another Sign The FDA Needs Help? - Forbes:

The Ranbaxy recall comes after a host of problems with Ranbaxy in recent years – including recalls, admissions of false testing data presented to the FDA, and other manufacturing problems. The troubles at Ranbaxy also point to the challenge a foreign drug company has when buying another drug company. Almost immediately after Daiichi Sankyo acquired a majority stake in Ranbaxy, problems sprang up.  With no expertise running an Indian generics drug company, let alone one that had been family controlled up to that point, DaiichiSankyo was blindsided by the troubles."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The Leader in GMP Compliance Training - The Best!
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Bad Pharma - Book Review

• FDA CGMP Online Training. Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses | Provided by SkillsPlus International Inc.

No doubt this will be a provocative read.  Follow the link to a comprehensive review of the book.

Science-Based Medicine » Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry:

"Closing thoughts
This is a book with important messages for patients, health care professionals, governments, and the pharmaceutical industry. It may anger, and even infuriate you. It should. Yet Goldacre sketches out a path for reform – one in which transparency is the rule, not the exception, and one in which the pharmaceutical industry can engage with the health care system in ways that will help it do what we all want it to do – bring innovative new medications to market that improve the health and welfare of patients. This change, however, will only come when we demand better – better from pharmaceutical companies, better from regulators, and better from our fellow health professionals. Ultimately, we’ll have the industry we deserve – if we’re not willing to demand better, we’re never going to see any improvements. This book is your call to action."

'via Blog this'

Order the book through Amazon.com:
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (Kindle Edition)

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Which sleep position is healthiest?

. . . I gather then, that sleeping on one's back is "beauty sleep."

Which sleep position is healthiest? - CNN.com:

"The Best:   - - - Back position - - -

Good for: Preventing neck and back pain, reducing acid reflux, minimizing wrinkles, maintaining perky breasts."

'via Blog this'

Pharma Forecast 2020: Cold Comfort

This summary article calls out a sobering list of things that are likely to put a damper on the pharma industry.

Pharma Forecast 2020: Cold Comfort:

"Despite such a bleak forecast, the report predicts “a golden era of renewed productivity and prosperity.” It recommends that above all, corporations should focus on collaboration with other players and academia, offer real-time outcomes data to establish value of medicines, reinvigorate corporate ethics standards, and use new procedures and technologies to revolutionize R&D. The message can be further condensed to something along the lines of: “Trim the fat and get with the times.”"

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Happy Holidays - Food Safety Tips - FDA & USDA

Let's Talk Turkey—A Consumer Guide to Safely Roasting a Turkey - from the USDA

Holiday Food Safety Video - from the FDA
(English)


(Seguridad de alimentos durante festividades - en español)


Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Asking for More Control Over Drug Compounding

F.D.A. Asking for More Control Over Drug Compounding - NYTimes.com:

"Among the changes proposed by Dr. Hamburg are requiring larger compounders to register with the F.D.A. and abide by its so-called good manufacturing practice [GMP], which requires drug producers to report any problems with their products to the agency. She is also recommending new labeling requirements that would make the origin and the risks of a compounded drug clear. She is also requesting that some products, including drugs with complex dosage forms, be banned for compounders.

“In light of growing evidence of threats to the public health, the administration urges Congress to strengthen federal standards for nontraditional compounding,” Dr. Hamburg stated in the written testimony. “Such legislation should appropriately balance legitimate compounding that meets a genuine medical need with the reality that compounded drugs pose greater risks than those that are evaluated by F.D.A.”"

'via Blog this'

You might also be interested in:
SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• Compounding pharmacies need FDA oversight (drughealth.blogspot.com)

AMA Wants To Stop Pharma Pay-To-Delay Tactic On Generics

The latest coming from the American Medical Association, the nation’s largest doctor group . . .

AMA Wants To Stop Pharma Pay-To-Delay Tactic On Generics - Forbes:

"An end to the drug industry practice that leads to drug makers legally paying a competitor to keep a cheaper generic off the market for potentially years would be bad news to drug makers like Abbott Laboratories (ABT), Pfizer (PFE) and others but good news for companies that operate pharmacies like Walgreen (WAG), CVS/Caremark (CVS) and Wal-Mart (WMT) which try to get consumers to switch to less expensive prescriptions."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

The Great American Smokeout - Quit Smoking

Updated 12/6/2022

BTW, the date varies each year.  The ACS says, "Let the Great American Smokeout event on the third Thursday in November be your day to start your journey toward a smoke-free life."

---  the original post follows below  ---

The Great American Smokeout | American Cancer Society:

"The American Cancer Society is marking the 37th Great American Smokeout on November 15 by encouraging smokers to use the date to make a plan to quit, or to plan in advance and quit smoking that day. By quitting — even for one day — smokers will be taking an important step towards a healthier life – one that can lead to reducing cancer risk."

'via Blog this'

FDA finds bugs, bird and contamination at Ameridose plant

• The best FDA cGMP online training courses, classes, and programs offered by SkillsPlus International Inc.

Updated October 27, 2022

The original link broke.

You still read about the same topic here:

FDA finds bugs, bird and contamination at Ameridose plant - NBC News

---  the original post follows below  ---

Really?!  They said what?!

FDA finds bugs, bird and contamination at Ameridose plant - Vitals:

"Ameridose officials defended the company's practices in a statement:

"While Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product, and have always been guided by Good Manufacturing Practices (GMP) referenced in federal regulations, Ameridose is committed to addressing all observations in order to enhance our existing systems. We are in the process of preparing a full response for presentation to the FDA.”"

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

Danger! Danger! Don't Eat Wild Mushrooms - Some Are Deadly

Updated June 24, 2023

The original link broke.

Read more about the topic here:

Wild Mushroom Warning. Mushroom Poisoning: Don't Invite "The Death Angel" to Dinner - National Capital Poison Center

---  the original post follows below  ---

How many times do we have to read about people getting sick or dying from eating poisonous mushrooms?!

Don't eat wild mushrooms, if you're not an expert!!!

Danger! Danger! People Don't Eat Mushrooms Some Can Be Deadly - Yahoo! Voices - voices.yahoo.com:

"Do not eat wild mushrooms…yes, they may look perfectly okay but there are so many mushrooms all over the East Coast right now and they're attracting people to fry or prepare them in casseroles and for steaks, chops, to enjoy their flavor. Watch out!! "There are deadly mushrooms that can grow in your lawn," said Rebecca Rader, executive secretary of the North American Mycological Association based in Christianburg, Virginia. Mycology studies fungi's which includes mushrooms.

"There are some that can kill you and many that can make you sick," said Rader."

'via Blog this'

List of 'Salty Six' Foods May Surprise You

I try my best to limit my salt intake, and found a couple of these a little surprising.

List of 'Salty Six' Foods May Surprise You - Breaking News, Local News, Local Weather, Local Sports:

"Researchers say the following “salty six” foods are the top sources for sodium in today’s diets: . . ."

1. Bread and rolls
2. Cold cuts and cured meats
3. Pizza
4. Poultry
5. Soup
6. Sandwiches

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

The Only Vote That Counts: FDA 483 Round-Up

The Only Vote That Counts: FDA 483 Round-Up:

"Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings.  But the FDAs real “votes” are in the 483s they issue.

Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training."

'via Blog this'

You might also be interested in:
Root Cause Analysis for Better Investigations - Live On-Site Training Course

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• FDA's Top Supplement Issues (drughealth.blogspot.com)

ECRI Names Top 10 Health Technology Hazards for 2013

ECRI Names Top 10 Health Technology Hazards for 2013 | HITECH Answers:

"What topics made the list?  Here’s the rundown:

1. Alarm hazards
2. Medication administration errors using infusion pumps
3. Unnecessary exposures and radiation burns from diagnostic radiology procedures
4. Patient/data mismatches in EHRs and other health IT systems
5. Interoperability failures with medical devices and health IT systems
6. Air embolism hazards
7. Inattention to the needs of pediatric patients when using “adult” technologies
8. Inadequate reprocessing of endoscopic devices and surgical instruments
9. Caregiver distractions from smartphones and other mobile devices
10. Surgical fires

Of particular interest to us is that for the first time, three Health IT-related topics made the Institutes annual list."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA’s Top Supplement Issues

FDA’s Top Supplement Issues:

"Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, gave a quick talk this morning at SupplySide West, touching on FDA’s top regulatory concerns for supplements. He said the most important topic is good manufacturing practices (GMPs), but that’s not the only supplement issue that’s currently top of mind to FDA.

In short, Fabricant said these are the most pressing industry issues: . . ."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, popular QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• FDA Warns Dietary Supplement Firms to Stop Promoting Unapproved Products as Drugs (drughealth.blogspot.com)

Poison-proof your home

poison-proof your home - South Florida Sun-Sentinel.com:

"The top 5 poisons toddlers enjoy placing in their mouths during playtime are:

• Household cleaners
• Medications
• Cosmetics and personal care products
• Foreign objects, such as coins and watch batteries
• Plants, berries and mushrooms"

'via Blog this'

A Regulatory App-ening - A mobile apps POV on FDA medical device regulations

Read this well-written point of view regarding the FDA's medical device regulations and how they impact mobile applications . . . are they or aren't they medical devices?!

Drugwonks | A Regulatory App-ening:

" . . . during the session on mobile apps as medical devices. At present, there are some 17,828 healthcare and fitness apps and 14,558 that can be deemed “medical.” As Vice President Biden said, “It’s a big f**kin’ deal.”

But when is an app a medical device and when is it not? Not surprisingly, it depends."

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturer - Learn the basics of the FDA's QSR regulations

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

Related articles

• Medical device firms growing in South Florida (skillsplusinfo.blogspot.com)
• What to do after a hurricane if you use a home medical device (drughealth.blogspot.com)

What to do after a hurricane if you use a home medical device

• People also search for California Home Medical Device Retailer Exemptee license training certification course - Buy now!

This article has good links off to additional information and resources

What to do after a hurricane if you use a home medical device:

". . . like an oxygen tank, ventilator, medical bed, wheel chair, or blood glucose monitor, losing power can be much more than an inconvenience. Your first step should be to call your electric company and fire department to let them know that you have a medical device that needs power. While you wait for power to be restored or help to come, here's some advice from the U.S. Food and Drug and Administration on what else to do: . . . "

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

CA HMDR Exemptee online CBT training certification - for HME DME retailers wholesalers

CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog

Compounding pharmacies need FDA oversight

Will Congress step in, to help the FDA?

Compounding pharmacies need FDA oversight - The Washington Post:

. . . Congress gave the FDA some oversight power in 1997 over compounding pharmacies, but several of the firms challenged the law in court. At issue was the FDA’s power to regulate their brochures and advertising. In 2002, the Supreme Court ruled for the pharmacies. Two appellate court decisions since then conflict about whether the original law is valid and enforceable. Congress has failed to clarify the situation. . .

"The federal government, Congress and the states all bear some blame for this lapse of oversight. There are proven methods to prevent contaminated medicine from reaching patients — methods that were simply not used in this case. Congress can remedy the situation by putting the regulation of large-scale drug compounding unequivocally under FDA control. The health and safety of Americans demand that government not fail a second time."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training - for pharmaceutical manufacturers

CA Designated Representative online training certification - for drug wholesalers
FL Designated Representative online exam preparation - for drug wholesalers
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Statement on NECC Fungal Meningitis Outbreak: Additional Patient Notification Advised

Fda (Photo credit: Wikipedia)

Drug Safety and Availability > FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised:

"At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), "

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors


CA Designated Representative online training certification - for pharmacy wholesalers
FL Designated Representative online exam preparation - for pharmacy wholesalers


CA HMDR Exemptee online training certification - for HME DME Retailers Wholesalers
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Ensuring high-quality dietary supplements with 'quality-by-design' - QbD

The U.S. Food and Drug Administration (FDA) regulates dietary supplements as a category of foods, rather than drugs.

Ensuring high-quality dietary supplements with 'quality-by-design':

"They concluded that a QbD approach — ensuring the quality of a product from its very inception — is the best strategy. One key step in applying QbD to dietary supplements, for instance, would involve verifying the identities of the raw materials — the plants — used to make supplements. “It is clear that only a systematic designed approach can provide the required solution for complete botanical characterization, authentication and safety evaluation,” they say."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - Effective GMP training, popular QSR training, highly recommended instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Drugs May Last Past The Expiration Date

What Expiration? Your Drugs May Last A Long Time // Pharmalot:

"Next time you decide to toss that prescription medicine because it appears to have expired, you may want to think twice. Why? A new analysis indicates that some prescription drugs retain their potency long after the expiration date, and the finding also suggests that the healthcare system could save untold oodles of money if expiration dates were sufficiently extended.

To wit, a team of researchers analyzed 14 different medications and found that 12, or 86 percent, tested at concentrations that were at least 90 percent of the amount on the labeling. Three actually had concentrations that exceeded the labeling; just two medications had less than 90 percent of the labeled concentration, according to a research letter published in the Archives of Internal Medicine"

'via Blog this'

For more information (link to the original Arch Intern Med article):
Stability of Active Ingredients in Long-Expired Prescription Medications

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - Popular cGMP training, best QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Top counterfeit drug events in 2012

The article provides links to the related drug event stories.

Top counterfeit drug events in 2012 - FiercePharma:

"This report points to some of the most significant events in the effort to address counterfeiting this year. Maybe you know of others not mentioned. It would be great if the report could start a public discussion of which steps need to be emphasized next. There is little question that more needs to be done, and it is best if it is done with some forethought. -- Eric Palmer"

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

CA Designated Representative online CBT training certification for drug wholesalers
FL Designated Representative online CBT exam preparation for drug wholesalers
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Food Inspections Fail To Catch Vast Majority Of Pathogens

FDA Food Inspections Fail To Catch Vast Majority Of Pathogens, 'Bloomberg Markets' Finds:

"The U.S. federal government has been fighting foodborne illness for a century, ever since Upton Sinclair terrified the country with The Jungle, his expose of the Chicago meatpacking industry. Many think these measures have been successful. House Republicans, for example, recently voted to cut the FDA's budget for food safety, using the argument that our food system is "99 percent safe."

Widely-touted statistics about the prevalence of food poisoning cast some serious aspersions on that idea. In 2011, 48.7 million Americans contracted a foodborne illness. Of those, 127,839 were hospitalized and 3,037 died."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA seeks to reargue cigarette-warning label rules

• People also look for FDA GMP online training courses

Updated July 6, 2021

The original link broke.

You can read more about the history of this topic here:

Federal appeals court strikes down FDA tobacco warning label law - CNN

---  the original post follows below  ---

My gut sense is that the proposed cigarette-warning labels would be effective. When I look at them, they make me feel uneasy.

FDA seeks to reargue cigarette-warning label rules:

"The agency in a filing today in the U.S Court of Appeals in Washington said the court's 2-1 ruling finding the regulations violated the free speech rights of tobacco companies under the First Amendment of the U.S. Constitution was wrong and conflicts with a ruling by a federal appeals court in Cincinnati.
The majority on the three-judge panel said in August that the government failed to present any data showing the warnings would cut smoking rates.

"The First Amendment does not require statistical proof of the extent to which the decline in smoking rates resulted 'directly' from the new health warnings," the FDA said in today's filing."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Shuts Down Thousands Of Illegal Internet Pharmacies

FDA Shuts Down Thousands Of Illegal Internet Pharmacies:

"The U.S. Food and Drug Administration has taken charge of a dangerous upturn in illegal online pharmacies that sell dangerous, unapproved medications to consumers.

In collaboration with international regulatory and law enforcement agencies, the FDA took legal action against more than 4,100 internet pharmacies via criminal charges, seizure of illegal products, and removal of websites.

This noteworthy bulletin comes directly in the midst of the 5th annual International Week of Action (IIWA), a joint venture to tackle the online sale and distribution of phony and illegal drugs."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
CA Designated Representative online CBT training certification by SkillsPlus Intl Inc.
FL Designated Representative online CBT exam preparation by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA unveils new device that detects counterfeit drugs

This CNN article has a great close-up photo of the device.

FDA unveils new device that detects counterfeit drugs – The Chart - CNN.com Blogs:

"CD3 is currently being used in 50 FDA field laboratories, as well as border crossings and import centers. It's also used in a number of international mail facilities including those in San Francisco, Los Angeles and Chicago and other points of entry, where inspectors screen drug ingredients, finished products and dietary supplements to identify counterfeit, falsified and unapproved drugs, cosmetics, foods, medical devices and cigarettes.

The battery-operated LED machine emits 10 different wavelengths of light like ultraviolet and infrared imaging and can be used on tablets and capsules, powders, and packaging (inks, papers and covert markings). It can also detect products that have been tampered with, re-labeled or re-glued. The CD3 has been used to analyze nearly 100 counterfeit products including drugs like Crestor, Lipitor, Oxycontin, Viagra, Tamiflu, Singulair, Plavix and Wellbutrin."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, highly recommended QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Sequestration: What Does it Mean for Pharma?

• Recommended FDA CGMP online training courses sold by SkillsPlus Intl Inc.

Sequestration: What Does it Mean for Pharma? - PharmExec.com:

"Overview
So let’s step back and take a look at all of this for a moment. Unless Congress gets it act together “H.R. 5872: The Sequestration Transparency Act of 2012” will go into effect on January 2, 2013. The impact of $110 billion being cut from the federal budget could no doubt lead to major losses in public and private employment, and a likely reduction of industrial capacity in many areas of the economy. All dire, and all very serious, especially at this time. But from the standpoint of the Rx industry, think about a few of the variables floating around this issue, too."

... would suggest it definitely could be tough sledding for the Rx business if the Sequester comes on line. For every employee of the Rx industry, it bears careful study.

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Drug Disposal - National Take-Back Initiative

Drug Disposal - National Take-Back Initiative:

"The Drug Enforcement Administration (DEA) has scheduled another National Prescription Drug Take-Back Day which will take place on Saturday, September 29, 2012, from 10:00 a.m. to 2:00 p.m. This is a great opportunity for those who missed the previous events, or who have subsequently accumulated unwanted, unused prescription drugs, to safely dispose of those medications.

The American people have again responded overwhelmingly to the most recent DEA-led National Prescription Drug Take-Back Day. On April 28th, citizens turned in a record-breaking 552,161 pounds (276 tons) of unwanted or expired medications for safe and proper disposal at the 5,659 take-back sites that were available in all 50 states and U.S. territories. When the results of the four Take-Back Days to date are combined, the DEA and its state, local, and tribal law-enforcement and community partners have removed over 1.5 million pounds (774 tons) of medication from circulation."

'via Blog this'

Find the nearest take-back collection site in your area:
DEA - Take-Back Initiative Collection Site Search

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, recommended QSR training, world-class instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA told to act on wireless hacks

FDA told to act on wireless hacks | StarTribune.com:

"Wireless technology is creating new possibilities for implantable medical devices, from monitoring heart rhythms from a world away to adjusting the amount of insulin a diabetic receives.

But according to a just-released U.S. Government Accountability Office report, such technology has also opened the doors to hackers.

As a result, the GAO is calling for the U.S. Food and Drug Administration to develop a plan enhancing its surveillance of medical devices. Part of that process will place a sharp eye on information security."

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturers - Live on-site QSR training - Learn the basics

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP (pharma/bio) training, best QSR (medical devices) training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA warning public of risks of online pharmacies

FDA warning public of risks of online pharmacies - Businessweek:

"Research by the National Association of Boards of Pharmacy, which represents the state pharmacy boards, found that of thousands of online pharmacies it reviewed, only about 3 percent follow state and federal laws. In fact, the group's website lists only a few dozen Internet pharmacies that it has verified are legitimate and following the rules.

Most consumers don't know that. An Internet survey, conducted by the FDA in May, questioned 6,090 adults. It found that nearly one in four Internet shoppers has bought prescription drugs online, and nearly three in 10 said they weren't confident they could do so safely."

'via Blog this'

For more information, visit the FDA's site and initiative:   FDA - BeSafeRx: Know Your Online Pharmacy

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - Popular GMP training, effective QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

L'Oreal Hit by FDA Warning Letter for Questionable Claims

Cosmetic Company L'Oreal Hit by Warning Letter for Questionable Claims > RAPS > News - Article View:

"When does a cosmetic product become a drug? When it’s marketed as having advanced features that alter the body's cellular state, explained the US Food and Drug Administration (FDA) in a warning letter sent 11 September 2012 to Lancôme USA, a subsidiary of cosmetics manufacturer L'Oreal.

The letter references a number of products marketed by Lancôme, many of which claim to promote a more youthful look and go by names like, "Génifique Cream Serum Youth Activating Cream Serum" and contain modifiers such as "Precious Cells Advanced Regenerating and Reconstructing Eye Cream."

Claims Allegedly Violate Federal Regulations
In its warning letter, FDA said the products' claims, contained on Lancôme's website, make claims indicating that they affect the function and structure of the human body, which would make them a drug as defined by the Federal Food, Drug and Cosmetic Act."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Takes On Mobile Health Apps

The FDA Takes On Mobile Health Apps - IEEE Spectrum:

"But the public health agencies, big pharmaceutical companies, and start-ups that have pushed out apps in the past few years have outpaced U.S. government regulators. While it’s assumed that some medical apps are subject to regulations, the U.S. Food and Drug Administration (FDA) has not defined the scope of its oversight and has issued few enforcement actions. 


That’s about to change. The agency is expected to finalize guidelines within the next two months for medical apps, more than a year after releasing draft guidelines. For the industry, the expected rules bring both relief and trepidation: App makers are eager for clarity on how much red tape they’ll encounter in the future, but they’re also nervous that overly broad rules will stifle innovation. 


While waiting for the final guidelines to be published, we surveyed notable industry figures on what they’d like to see in the rules. Here are their top-five requests to the FDA." . . .

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR (medical devices) training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

PharmTech Talk - LIVE from PDA FDA Joint Regulatory Conf 2012

PharmTech Talk » LIVE from PDA FDA Joint Regulatory Conference 2012:

"Be sure to follow our Twitter feed from this year’s PDA-FDA Joint Regulatory Conference, taking place in Baltimore, at Twitter@PharmTechAngie or Twitter@PharmTechGroup. Today’s sessions focused on common regulatory citations (the word is that they haven’t changed much in the past 10 years), new ways to handle internal investigations from Big Pharma organizations such as Amgen and Abbott (including a bit of an audience stirup surrounding the management, or lack thereof, of Class I investigations), FDA encouragement of sending novel excipients in for review, best practices for selecting excipients for new drugs (including how to best deal with suppliers), updates on ICH Q11, and a lot of information on knowledge management, risk-based approaches (including QbD), and lifecycle approaches."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, superb QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

New FDA Device Helps ID Fake Drugs

• You might also be interested in FDA CGMP Online Training - trusted FDA GMP online training courses offered by SkillsPlus International Inc. 

New FDA Device Helps ID Fake Drugs:

"The FDA is using simple technology it designed to help nab counterfeit products, but the agency's development of such innovations may face trouble in the future, agency commissioner Margaret Hamburg, MD, said Monday.

The agency displayed its Counterfeit Detection Device No. 3 -- CD3 for short -- at an FDA symposium.

The device sprays 10 different wavelengths of visible and invisible light on products the FDA is inspecting. When they aim it over tablets, boxes, and accompanying documents, inspectors are able to spot counterfeit products and documents because they appear a different color or shade.

"It doesn't tell you what the problem is," explained R. Duane Satzger, PhD, director of the FDA's Forensic Chemistry Center. "It just lets you know there's a difference.""

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Warns Dietary Supplement Firms to Stop Promoting Unapproved Products as Drugs

FDA Warns Dietary Supplement Firms to Stop Promoting Unapproved Products as Drugs:

"Under the Federal Food, Drug, and Cosmetic Act (FFDCA), a product is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. New drugs may not be legally marketed in the United States without prior FDA approval.  Although Neuro Impact, NeuroPruTect, and Omega3PruTect are marketed as dietary supplements, they are promoted as drugs through claims made on the firms’ websites.

“The FDA has taken these actions because companies may not sell new drugs unless the drugs have been tested by the sponsor and approved by FDA, and they may not make false or unsubstantiated claims about drugs they sell,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Products with unapproved claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.”"

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Will FDA CDRH Soon be Reviewing Video Games? ... as medical devices

 . . . the expanding scope of medical device regulations over mobile apps, and now possibly video games:

Will CDRH Soon be Reviewing Video Games? > RAPS > News - Article View:

"Video games aren't traditionally known as medical devices. In fact, there aren't yet any approved by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), the US's medical device regulatory body. But all that could soon be changing.

At least one company, Boston and San Francisco-based Akili Interactive Labs, is on the verge of taking a video game it has specifically tailored for the treatment of attention deficit/hyperactivity disorder (ADHD) before FDA for potential approval.

Akili's game, named "Project: Evolution,” would work on the presumption of prior research that action-oriented video games can improve a person's concentration. The advantage for the game would be the almost-total mitigation of side effects, likely giving it a highly positive risk-benefit assessment even if it doesn't prove as effective as first-line treatment for ADHD."

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturers - Basic FDA QSR Training

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, superb QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Looking to Overhaul Compliance Approach

• FDA GMP QSR cGMP Online Training - GMP online training courses provided by SkillsPlus International Inc.

FDA's proposed solution is being dubbed "The Case for Quality"—a tripartite approach consisting of a focus on quality, enhanced transparency and stakeholder engagement.

FDA Looking to Overhaul Compliance Approach > RAPS > News - Article View:

"The US Food and Drug Administration (FDA) is headed toward a marked change in compliance policy in the coming years as the result of rapidly surging imports of pharmaceutical, medical device and biologics products, according to Mark Roh, regional food and drug director for FDA's Pacific Region. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - Popular GMP training, recommended QSR training, the best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA investigating claims of penny, plastic found in Penn State's campus ice cream

FDA investigating claims of penny, plastic found in Penn State's campus ice cream; Penn State Takes Action to Ensure Ice Cream Safety - WPMT:

"Penn State officials have sought the assistance of the Food and Drug Administration (FDA) to investigate four recent incidents involving the discovery of foreign objects in half-gallon ice cream containers sold at its campus creamery. The University also is taking steps to make its product safer on the shelf."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Approves Swallowable Sensor That Tracks Health From The Inside

FDA Approves Swallowable Sensor That Tracks Health From The Inside:

"The US Food and Drug Administration has approved an ingestible digital sensor that can be swallowed in a pill to track health data from inside the body. The idea is that the data can be used not only by patients themselves, but also by caregivers and doctors to individualize their care.

The ingestible sensor, formerly known as the Ingestion Event Marker or IEM, is already approved for use in Europe.

It is the first "digital pill" to receive FDA approval, in a move that its maker Proteus Digital Health, whose headquarters are in Redwood City, California, sees as the start of a era where digital medicine "shifts the care paradigm"."

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturers - High Quality QSR Training

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Highly Recommended QSR Trainer & GMP Trainer Certification

Updated January 11, 2021

GMP Trainer Awareness, Certification, and Master Trainer Courses (online courses)

This online self-study course leads participants through many different ways to teach cGMPs and QSRs. Learn what a class instructor thinks while delivering a training session to students, so you can repeat that training approach in your own organization. 

Questions? Call us: (415) 948-5220

- - -  original post follows below  - - -

Highly Recommended QSR & GMP Trainer Certification | SkillsPlus International Info:

"GMP & QSR Trainer Certification Program
(offered as a public seminar Oct 22-26, 2012 in San Francisco, CA)

Refine your skills and become the best QSR or GMP trainer that you can be!

Learn about things to do in San Francisco:  San Francisco Travel for Visitors

This is a five-day class where participants experience many different ways to teach CGMPs and QSRs. Then learn what your instructor is thinking about during sessions so that you can repeat that training approach in your organization. Students make 2 presentations demonstrating their skills during the class. This class is suitable for food and dietary supplement manufacturers also."

'via Blog this'

Learn more about about: cGMP/QSR Trainer Certification Program


Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

Global AIDS Conference Wraps Up

Updated October 8, 2022

The original post didn't age well.

You might be interested in viewing a list of upcoming HIV/AIDS conferences here:

IAS Events

---  the original post follows below  ---

Global AIDS Conference Wraps Up:

"Michel Sidibe, the executive director of the United Nations Program on HIV/AIDS said there needs to be more cure research.

"Today we should not just say, 'okay, let us have treatment.'  We should say, 'why not a cure?  Why not a vaccine?' That is the area where we need to put our energy, and that will bring us certainly to the end of this epidemic," he said.

Activists disrupted sessions and panels to demand greater funding and resources for research and for those living with HIV and AIDS. "We can end AIDS!  We can end AIDS!" were among the slogans heard at the gathering."

'via Blog this'

For more information:  AIDS 2012 Home

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

An Internal Failure To Innovate Is America's Greatest Global Threat - Biopharmaceuticals

"The $900 billion U.S. biopharmaceutical industry is a critical force in the U.S. economy. It supports some four million American jobs, including more than 650,000 jobs in the industry itself. The average biopharma wage is nearly twice the U.S. private sector average, $119,000 versus $64,000 – reflecting the value created by pharmaceutical innovation."

An Internal Failure To Innovate Is America's Greatest Global Threat - Forbes:

"Just this month, we learned that the U.S. dropped to 10th place in the 2012 Global Innovation Index, down from 7th place the year before. The index, published by the international business school INSEAD and the World Intellectual Property Organization, ranks 141 nations on nearly 100 factors related to innovation; the top two countries, for two years running, are Switzerland and Sweden.

The report said the biggest area of concern for the U.S. was a drop in “human capital and research” – which includes K-12 and college education, as well as R&D.  In these areas so critical to future innovation, the U.S. ranking fell from 13th in 2011 to 22nd this year."

'via Blog this'

FDA's Unique Device Identification (UDI) System - Free FDA Video

FDA's Unique Device Identification (UDI) System:  <--- follow this link to the FDA's free video

"FDA has issued a proposed rule on the establishment of a Unique Device Identification System. This system would require most medical devices distributed in the U.S. to carry a Unique Device Identifier (UDI). This system, comprised of the UDI code, application of the UDI to device labeling and packaging, and a related database, is designed to provide a standardized way to identify devices across all information sources and systems, including electronic health records and devices registries."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA approves first drug for reducing the risk of sexually acquired HIV infection

This is considered pivotal in the 30-year battle against AIDS.

Press Announcements > FDA approves first drug for reducing the risk of sexually acquired HIV infection:

"Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.

The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.

As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, popular QSR training, respected instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Fat-melting device a weighty matter for FDA - It has not been approved

Fat-melting device a weighty matter for FDA - Open Channel:

"But there’s a problem: The LipoTron, which targets fat with radiofrequency waves, has never been cleared or approved by the U.S. Food and Drug Administration, which would make it illegal under federal law to sell or promote it for weight loss.

The FDA is aware of the activity. But an investigation by FairWarning found that the agency has not taken enforcement action — even though it has known about the situation at least since January, 2010. At that time, two whistleblowers, one a former LipoTron distributor, provided sales records and a trove of other documents to an FDA criminal investigator."

'via Blog this'

You might also be interested in:
Essentials for Medical Device Manufacturers - The best basics QSR training course available

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• When Does An App Need FDA's Blessing? (drughealth.blogspot.com)

FDA Surveillance of Scientists Spread to Outside Critics

Really kind of surprising.

What's worse is that some of the information and documentation inadvertently got exposed on the web.

F.D.A. Surveillance of Scientists Spread to Outside Critics - NYTimes.com:

"What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort."

'via Blog this'

Changes Coming to FDA QSR for Prefilled Injection Devices

Manufacturers of prefilled drug delivery devices and their components need to begin preparing for compliance with the coming quality system regulation for combination products.

The following article is a very well written analysis of the situation, with very practical recommendations on how to get ready for the necessary changes.

Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices > RAPS > Features - Article View:

"The rule is expected to require combination product manufacturers to comply with both Current Good Manufacturing Practice regulations for drugs and biologics (21 CFR 210, 211 (CGMP)) and the Quality System Regulation for medical devices (21 CFR 820 (QSR)), during and after formation of a combination product. This has significant implications for pharmaceutical and medical device manufacturers that produce medicated devices, prefilled drug delivery devices and their components."

'via Blog this'

You might also be interested in:
Olympics for Medical Device Manufacturers - Exciting & Fun QSR Training

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store