Sunday, December 23, 2012

FDA Exerts FSMA Authority - Food Safety

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. "

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Tuesday, December 18, 2012

GMP Master Training Plans - Free Tips (Video)

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

 

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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."

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Wednesday, December 5, 2012

FDA Public Hearing on Antiseptic Patient Preoperative Skin Preparation Products

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"

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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

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What You Should Know for the 2012-2013 Flu Season - from the CDC

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:
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Tuesday, December 4, 2012

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."

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Saturday, December 1, 2012

FDA on the Ranbaxy Atorvastatin Recall

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 . . . "

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World AIDS Day - FDA Voice

Fda
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."

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Friday, November 30, 2012

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."

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Tuesday, November 27, 2012

FDA and Supplement Regulations

Updated 11/7/2015:

You might have been looking for these:

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

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.

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."

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FDA Closes Down Another Dietary Supplement Company

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."

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Saturday, November 24, 2012

Ranbaxy Generic Lipitor Recalled

English: Logo of Ranbaxy.
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."

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Friday, November 23, 2012

Bad Pharma - Book Review

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."

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

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Tuesday, November 20, 2012

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."

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Saturday, November 17, 2012

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.”"

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Thursday, November 15, 2012

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 espaƱol)


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Wednesday, November 14, 2012

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.”"

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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."

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Tuesday, November 13, 2012

The Great American Smokeout is Thurs Nov 15, 2012 - Quit Smoking

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."

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FDA finds bugs, bird and contamination at Ameridose plant

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

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."

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Friday, November 9, 2012

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

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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."

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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."

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