Wednesday, December 30, 2009

FDA Most Common Drug and Device 483 Items

The AssurXblog post, The Most Common Drug and Device GMP 483 Items, reports 6 common FDA GMP drug 483 items, and 5 common FDA GMP medical device 483 items. You'll want to read them all, and here are teasers from each category:

Drug GMP FDA-483 (observational) items:

  • Responsibilities and procedures of the Quality Control unit are not in writing
The most common Medical Device GMP FDA-483 (observational) items:
  • Deficiencies in complaint file system

Monday, December 28, 2009

Pharma Mergers - 2009 review - 2010 predictions

Continuing the thread of the pharma year in review, and what 2010 might look like. Here's a Motley Fool look at 2009 and 2010 from the perspective of pharmaceutical mergers and acquisitions, 2009: The Year Pharma Learned to Love Itself. In a nutshell:
  1. 2009 ushered in a number of consolidations
  2. Consolidations might not work well or scale well due to the challenges of integration
  3. The author, Brian Orelli predicts for 2010, "While anything is possible, I wouldn't expect much more consolidation of major drugmakers."

Return Home: http://drughealth.blogspot.com/ 

Saturday, December 26, 2009

FDA Holiday Food Safety

The holidays are about spending time with friends and family. Naturally, food will be served and shared. So beware! Take a few moments to review best food handling practices to keep everybody happy and food healthy! Follow these FDA food safety recommendations, Food Safety Tips for Healthy Holidays, or download this newsletter, Food Safety Tips for Healthy Holidays (pdf)


Bottomline...
  1. Clean
  2. Separate
  3. Cook
  4. Chill

Previous Posts: Happy Thanksgiving - Celebrate These Food Safety Tips 

 Return Home: http://drughealth.blogspot.com/


Wednesday, December 23, 2009

Cramer - Top 4 Healthcare Predictions for 2010

Economic Map of the World: Emerging Markets an...Image via Wikipedia

... rather, that's Cliff Cramer. In looking for 2010 trends, and predictions, I stumbled across his predictions, Top 4 Healthcare Predictions for 2010. It's the start of an interesting and provocative discussion of his 4 predictions (which I've truncated):
  1. Multi-national pharmaceutical and medical technology companies will increase their investments in emerging markets.
  2. Information technology will make greater strides in a healthcare industry.
  3. Healthcare reform will continue across developed and developing markets.
  4. Consolidation will be a major theme in 2010.

I recommend you go to his post, and jump into the discussion. On some gut level, I'm hoping the predictions ring true as my retirement investments will benefit.

Previous Posts: Biotechnology Trends 2010 - Free Report 

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Monday, December 21, 2009

FDA Cosmetics GMP Inspection Checklist - Free

Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics


The FDA offers a Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for cosmetic establishment instructions, that are excerpted from the FDA's Inspection Operations Manual. The FDA checklist may serve as guidelines for effective self-inspection. According to the FDA, a good inspection score means that an establishment follows good manufacturing practice.

Previous Posts:
30 FDA GMP Compliance Tips
FDA Audit Preparation - Audit Theory - Be Ready

You might also be interested in:

Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.
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Saturday, December 19, 2009

FDA Unapproved Drugs Initiative

There are prescription and over-the-counter (OTC) drugs marketed illegally without FDA approval. The manufacturers of drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. These manufacturers circumvent the FDA approval process. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern. The FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Therefore, the FDA has crafted an entire suite of web pages that help manufacturers of unapproved drugs navigate the regulatory landscape, Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval


Here's what you can find: FDA's Concerns About Unapproved Drugs Background Information Unapproved Drugs Initiative Compliance Policy Guide Enforcement Actions Important Documents Publications Industry Information Unapproved Drug Decision Tree Unapproved Drugs Coordinator Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator Marketed Unapproved Drugs Workshop Required reporting of adverse events Health Care Professional Information Determining if a drug is FDA approved Orange Book NDC Directory http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ssLINK/ucm119742.htm#drugsatfda Legal mechanisms to access unapproved drugs Reporting of adverse events Consumer Information But best of all, they offer a FDA WebLearn Course: Bringing an Unapproved Drug into Compliance. You can get a sense of the content by scanning the companion FDA's Bringing an Unapproved Drug into Compliance - Course Script (PDF)

Wednesday, December 16, 2009

Biotechnology Trends 2010 - Free Report

English: Public domain image from cancer.gov h...Image via Wikipedia

Here's the next installment of my hunt for 2010 trends, forecasts, and predictions. Pharma-Reports.com just announced the availability of its executive report, Biotechnology Trends 2010 (free). I've provided the link to the request form. The report examines the most significant trends in biotechnology and their impact on rising health care costs, the aging population, and an overall rise in the incidence of disease. The report also discusses scientific advancements in proteomics and biomarkers, molecular manufacturing, and the development of smart materials.


Monday, December 14, 2009

FDA New Guidance on PET Drugs GMPs

This FDA guidance, Guidance - PET Drugs — Current Good Manufacturing Practice (CGMP), is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.

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If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
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Saturday, December 12, 2009

Say No To Drugs PSAs - Public Svc Announcements over the yrs

Updated April 21, 2017
This post didn't age well. The video links have broken, so I've removed them from the original post. You can get a sense of the video with this collection of photos:
PSAs Say No to Drugs

- -  most of the original post follows below  - -

I was catching up with news this wet Saturday morning and ran across this CBS News mini-history of anti-drug messaging over the years. Enjoy!

For related photos and links specific to this video clip go to CBS News PSAs Say No to Drugs Photos.

Previous Posts:
Sugar As Addictive As Cocaine Or Heroin
Epidemic Teen Addiction To Prescription Drugs (video)
Parents, Get A Clue About Teen Drug and Alcohol Abuse
Are Your Teens Abusing Drugs? - 4 Tips

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Monday, December 7, 2009

FDA - Food Defense Tool - CARVER + Shock

Updated March 18, 2021

The original link broke.

People also search for:
AN OVERVIEW OF THE CARVER PLUS SHOCK METHOD FOR FOOD SECTOR VULNERABILITY ASSESSMENTS

---  original post follows below  ---

The FDA of the U.S. Department of Health and Human Services and the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) have created an online tool to help farmers and producers assess and mitigate vulnerabilities in their production processes. The risk assessment tool (free software) called Agriculture CARVER + Shock is designed to help the food industry at the farm level – implement food production security methods. CARVER + Shock is an offensive targeting prioritization tool adapted from the military version (CARVER) for use in the food industry. The tool can be used to assess the vulnerabilities within a system or infrastructure to an attack. It allows the user to think like an attacker to identify the most attractive targets for an attack. By conducting a CARVER + Shock assessment of a food production facility or process, the user can determine the most vulnerable points in their infrastructure, and focus resources on protecting the most susceptible points in their system. 

Previous Posts: 

Saturday, December 5, 2009

HIV AIDS - 97 US Medicines in Testing - PharmaTimes

The Red ribbon is a symbol for solidarity with...Image via Wikipedia

This is a really nice snapshot of some of the clinical testing going on in the HIV AIDS field, PhRMA's Pharmaceutical Researchers Are Testing 97 Medicines And Vaccines for HIV and Related Conditions. The article provides a quick overview for medicines grouped by:
  1. Anticancer
  2. Antiviral
  3. Gene therapy
  4. Immunomodulators
  5. Vaccines
  6. Other

Previous Posts: Abzymes Pinpoint The HIV Achilles Heel 109 HIV Drugs And Vaccines Under Development Listen To People With AIDS and HIV (audio)

Return Home: http://drughealth.blogspot.com/ 

Saturday, November 28, 2009

Bah Humbug - Oh, that should be Bed Bug!

I just read a newspaper article reporting that users of http://www.bedbugregistry.com/ have been reporting the most complaints in Toronto and Vancouver. I checked out the "registry" and find it both fun and enlightening. Check it out! 



Wednesday, November 25, 2009

Looking Ahead to Pharma 2010 - Through the IBM innovation lens

IBM Global ServicesImage via Wikipedia

2010 is approaching fast. This is the time of year I start watching out for crystal ball predictions of what's in store for us. For example, check out IBM's vision for 2010, Pharma 2010: The Threshold of Innovation (pdf)

Monday, November 23, 2009

GMP Training - The end is near - I mean 2009!

Yep, the year is coming to a close. If 2009 snuck up on you and you still have some training needs, it's not too late. Arranging some onsite training might be challenging, but it's not too late to identify vendors that offer products and services that you can leverage. For example, buy some modules or materials, so that you can deliver training yourself. Or, locate vendors that offer online delivery of training via CBT (computer based training), so that you don't have to spend an arm and a leg to bring in a trainer on-site. The fastest way to find vendors who can help you, is to use www.google.com and search on "gmp training". 2009 is almost gone, and it's time to start planning your 2010 regulatory training plan. 


Saturday, November 21, 2009

Happy Thanksgiving - Celebrate These Food Safety Tips


I love gathering with family at this time of year. Let's just be sure we do it with food safety in mind. Here's a collection of previous posts you might be interested in: Time To Talk About Turkey Cooking and Food Safety Thanksgiving Alert - Cooked Turkey Can Still Cause Food Poisoning! Wine Lovers Dishwasher Magnet 

Wednesday, November 18, 2009

More Good News - Fighting Drug Counterfeiting - PQM

Learn about the latest worldwide effort to fight substandard and counterfeit drugs, in this PharmTech Talk article, USP and USAID Launch New Program to Improve Drug Quality. In a nutshell, Alexis Pellek writes:

"The $35-million program, called Promoting the Quality of Medicines (PQM) will work to improve the safety of medicines in approximately 30 countries worldwide by working to strengthen regulatory bodies, increasing the supply of legitimate products, detecting and reducing availability of counterfeits through testing and other methods, and raising public awareness of the dangers of substandard drugs."
Previous Posts: FDA Draft Guidance on Anti-Counterfeiting FDA On Drug Counterfeiting FDA - Global Drug Supply Chain Needs Better Oversight 

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Trackback url: http://blog.pharmtech.com/2009/11/06/usp-and-usaid-launch-new-program-to-improve-drug-quality/trackback/

Monday, November 16, 2009

FDA CFR Title 21 Database Search Page - Excellent!

Initially, I wasn't too thrilled about the FDA website getting re-designed. Now I'm starting to like what I'm seeing. For example, I'm seeing more user friendly pages like the CFR Search page. If you don't have the Search CFR Title 21 Database page bookmarked, you really should. It's a terrific database search tool for finding CFR contents by:

  • Section number
  • Part number
  • Full text search

Return Home: http://drughealth.blogspot.com/ 


Wednesday, November 11, 2009

Global Supply Chain - Counterfeiting - Sobering

This Q & A article from PharmTech is an interesting read, Preventing counterfeits from entering the supply chain. I find it sobering that a small percentage of drugs are counterfeit, yet counterfeited drugs represent a growing and substantive volume of tampered, contaminated, diluted, substituted, adulterated, and misrepresented ingredients. 



Saturday, November 7, 2009

AMA Unveils Flu Assessment Tool

Structure of the influenza virion. The hemaggl...Image via Wikipedia

The American Medical Association (AMA) launched AMAfluhelp.org, a comprehensive Web-based patient flu health-assessment program. It walks patients through a series of questions to determine the severity of their flu symptoms based upon the latest Centers for Disease Control (CDC) and Prevention guidelines. With the influenza state of emergency with us, you can never have too many of these useful gadgets and widgets around. 



Friday, November 6, 2009

FDA FAQ On IV Peramivir To Treat H1N1 Flu

Updated October 24, 2023

The original links broke.

You might also be interested in:

---  the original post follows below  ---

Recently, the FDA Says Yes to IV Peramivir To Treat Flu. Now here's the FDA followup with Peramivir IV Questions and Answers for Health Care Providers. It's a pretty comprehensive collection of over 20 questions and answers, and concludes with a set of related links. 

Wednesday, November 4, 2009

FDA Medical Device Online Courses In Chinese - Free

Here's more from the FDA's CDRH Learn treasure trove of free online courses. ... and these are in Mandarin Chinese! As of this posting, there's only one FDA CDRH Learn course in Mandarin, but you can expect more courses to be on their way. Here's what's available so far: Quality System Regulation 21 CFR Part 820 Basic Introduction Online Video Presentation Transcript 


Monday, November 2, 2009

FDA Medical Device Online Courses - Free

This is a great example of your government dollars working for you.

The FDA offers several free CDRH Learn online courses. These courses are intended for industry on safety and effectiveness of medical devices and exposure to radiation from medical devices.

Here's what's neat about the courses. Each course includes a captioned video, slide set, and post-test.

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

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!











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Saturday, October 31, 2009

FDA And Others To Study Lasik Problems

A subconjunctival hemorrhage is a common and r...Image via Wikipedia

After having a conversation about Lasik complications with a co-worker, I thought I'd share this article with you, from the LA Times, Three federal agencies to assess potential Lasik problems. As much as I'd like to get Lasik corrected vision, I'm very reticent to do so. My co-worker has looked into this matter for herself, and she tells me that the 2% complication rate is the best possible scenario. This low rate in part is due to: the usage of the best equipment, and the procedure being performed at the hands of a well-trained practitioner who's completed many thousands of procedures. As for me, even a 2% complication rate is too much risk for me. How about you? 

Friday, October 30, 2009

FDA Says Yes to IV Peramivir To Treat Flu

The FDA announced today that it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons:

  • the patient is not responding to either oral or inhaled antiviral therapy, or
  • when drug delivery by a route other than an intravenous route -- e.g., enteral (absorbed by the intestines) or inhaled -- is not expected to be dependable or feasible;
  • for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.
I've been following this drug for sometime now, and I'm glad to see that it's found a niche during this flu pandemic. Additional Related Information From The FDA: EUA Letter of Authorization EUA Fact Sheet for Health Care Providers EUA Fact Sheet for Patients and Parents/Caregivers Information for Healthcare Professionals Sheet (HCP) on mandatory adverse event reporting for emergency use of peramivir under EUA 


Wednesday, October 28, 2009

Procedure For FDA GMP Training

Don't forget the basics! Read this classic Jim Vesper article, Defining Your GMP Training Program with a Training Procedure. Make sure you've got some well-thought out standard operating procedures that define your FDA GMP training program. 



Monday, October 26, 2009

IMS Predicts Pharma Growth in 2010

I can hardly believe 2009 is almost over. It's time to start looking ahead to 2010 trends. I caught this article on Pharmaceutical-ManufacturingNews.com, IMS Forecasts Global Pharmaceutical Market Growth Of 4 - 6% In 2010. IMS Health forecasts 4-6% growth in 2010, and 4-7% through 2013. 

Saturday, October 24, 2009

Obese To Pay More For Health Insurance - Controversy (video)

Updated July 12, 2021

The original link/video is no longer available.

You might also be interested in:

---  the original post follows below  ---

Wow! What a lightning-rod this can become. Lifestyle choices and health conditions driving potential increases in health insurance coverage costs. Watch this MSNBC news video, as it discusses North Carolina's intention to make state workers who are morbidly obese, pay more for their health insurance, Should weight impact your health costs?

Friday, October 23, 2009

FDA Search Widget of Fraudulent H1N1 Products

Updated March 10, 2022

The original links are no longer available.

You might also be interested in:

---  the original post follows below  ---

H1N1 Fraudulent Products

This FDA widget helps you find out if a product you're interested in is legitimate or a fake.
I commute on public transportation every day. We're in the height of cold and flu season. I'm not likely to try any of these products, but if you're interested, check them out before you buy them. Let the buyer beware!

Launch FDA widget:
H1N1 Fraudulent Products

Previous Posts:
Got Wine Flu?
Flu.gov Updated by HHS - New Resources Added
FDA Posts Current Flu Info and Resources
Swine Flu Increases Demand For Masks (video)
Treat The Flu With Red Wine?!

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Wednesday, October 21, 2009

FDA Releases Hearing Aids Guide Online

Behind the ear aidImage via Wikipedia

The Food and Drug Administration (FDA) launched a new website that benefits current and potential users of hearing aids, A New Online Guide to Hearing Aids.

The site includes sections on:

  • general information on hearing aids
  • types of hearing loss
  • types and styles of hearing aids
  • how to get a hearing aid
  • benefits and safety of hearing aids
  • hearing aids and cell phones
  • other products and procedures that people can use to improve hearing

This is of interest to me as I grow older, and my siblings are showing signs that they might benefit from these devices.

Return Home: http://drughealth.blogspot.com/ 

Monday, October 19, 2009

FDA Says Flush Certain Medications

When thinking about throwing away medications, be sure to consider family, pet, and environmental safety. The FDA just released more information about how to dispose of certain medications, Disposal by Flushing of Certain Unused Medicines: What You Should Know. These certain medicines appear to be highly potent drugs with a high potential for abuse. There's more to this than just flushing prescriptions down the toilet. To learn more about this go to these additional resources:

How to Dispose of Unused Medicines Medication Disposal: Questions and Answers Federal Guidelines for Proper Disposal of Drugs Environmental Protection Agency 


Return Home: http://drughealth.blogspot.com/ 


Saturday, October 17, 2009

Got Wine Flu?

Sorry, I couldn't resist. I hope you find this amusing, What Is Wine Flu? Just in case you really wanted info on the swine flu, check out the CDC 2009 H1N1 Flu (Swine Flu) web pages



Friday, October 16, 2009

Recent HIV Vaccine Study Results - Could be disappointing

None - This image is in the public domain and ...Image via Wikipedia

Updated January 14, 2024

You might also be interested in:

---  the original post follows below  ---

Optimism generated from a recent HIV vaccine study conducted by the US Army & Thailand, might not be justified after all, reports this Wall Street Journal article, Data Call Into Question HIV Study Results. The statistical analysis is discussed, and calls into question the conclusions reached and recently publicized. I think there's more to come on this. 


Monday, October 12, 2009

FDA Warns of CT Scan Radiation Overdoses

This KWTX news article reports a hospital's problem with CT brain scan radiation overexposure, FDA Warns Hospitals About CT Brain Scan Radiation. The excessive dose problem was identified when a patient reported hair loss after a scan. The end result, the FDA has posted a notification, Safety Investigation of CT Brain Perfusion Scans: Initial Notification


Saturday, October 10, 2009

Flu.gov Updated by HHS - New Resources Added

The government's Department of Health and Human Services (HHS) unveiled several new resources on the federal government's one-stop resource for flu information -- https://www.cdc.gov/flu/. Some of the new items include:

  • A self-evaluation guide
  • A myth and facts section

Stay well!

Return Home: http://drughealth.blogspot.com/ 

Friday, October 9, 2009

FDA Guidance - Device Registration and Listing Requirements

Updated January 27, 2021

The links in the original post broke.

You might also be interested in:

- - -  original post follows below  - - -

The Food and Drug Administration (FDA) announced the availability of the guidance entitled "Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.'' The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements. The guidance also describes the information that owner/operators of device establishments must submit to register their establishments and list their devices electronically, using FDA Form No. 3673. Those owner/operators seeking a waiver from the electronic submission requirement must submit their requests in writing to FDA with a complete explanation of why their registration and listing information cannot reasonably be submitted electronically. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs). 

Saturday, October 3, 2009

Research Suggests Green Tea Promotes Weight Loss

Japanese green teaImage via Wikipedia
This just in, Effects of Catechin Enriched Green Tea on Body Composition.

In a nutshell:
  • New research from China has found that regular consumption of green tea - which is rich in naturally-occurring tea actives called catechins - can significantly and positively effect body composition in moderately overweight individuals.
  • The authors concluded that regular consumption of green tea with very high catechin content can, over a 90-day period, significantly reduce body weight, body fat mass and waist size in moderately overweight Chinese individuals.
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Friday, October 2, 2009

LSD Research Returns - FDA and Regulatory Oversight

Lysergic acid diethylamideImage via Wikipedia

What a surprise to read this fascinating San Francisco Chronical article, LSD's long, strange trip back into the lab. According to the article:

It still isn't easy to get an LSD study off the ground. Researchers must get permission from the U.S. Food and Drug Administration and the Drug Enforcement Administration plus state regulators, and they need approval from the institution they work for. Then they have to get approval for the source of the actual drug - in the case of UCSF, researchers are using LSD that was manufactured years ago in Switzerland.

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Wednesday, September 30, 2009

FDA Releases Proposed Guidance On Combination Products

Updated February 11, 2021

Links broke in the original post.

You might also be interested in:
FDA - Combination Products Guidance Documents

Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
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- - -  original post follows below  - - -

This Federal Register notice announces the FDA release of a proposed rule on combination products, Current Good Manufacturing Practice Requirements for Combination Products (pdf). According to the FDA Law Blog post, FDA Issues Proposed Rule on cGMPs for Combination Products:

The proposed rule does not independently establish new requirements, rather, it clarifies which set of existing cGMP regulatory requirements apply when drugs, devices, and biological products are combined to create a combination product.
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Saturday, September 26, 2009

Series About Wine And Your Heart


I ran across this information packed and thought provoking series about wine and your heart. It consists of 3 parts:

Ellen Mack, M.D., M.P.H., the author, says:

The first two parts (see Part 1 &Part 2) of the series Wine and your Heart examined some of the vast epidemiological and scientific evidence that moderate consumption of wine is associated with decreased cardiac mortality. Is this information being put to good use?

For me, this all means, drink a little to be healthy. Cheers!

Previous Posts: Men - Study Says Drink Wine and Live Longer Epidemiological Reasons To Drink Alcohol For Health Australian Wine Doctor Says Drink His Wine For Health

For Wine Lovers: Wine Lovers Dishwasher Magnet Champagne In The Freezer - Reminder Magnet Wine In The Freezer - Reminder Magnet (10 pack) Ask About Our Wines Magnet (10 pack) Return Home: http://drughealth.blogspot.com/ GMP Posters The Health, Drug, Prescription, and GMP Supersite Gift Store 



Wednesday, September 23, 2009

Upton Sinclair Belated Birthday - Inspired FDA Creation

Chicago meat inspectors in early 1906Image via Wikipedia
Happy Birthday, Upton Sinclair, Muckraking Journalist and Author of "The Jungle"

He was born on September 20, 1878.

Among his notable accomplishments, according to the article above:
. . . nothing Sinclair wrote ever eclipsed the fame of his exposé, “The Jungle.” The 1906 novel was intended to spotlight dangerous and unfair working conditions in turn-of-the-century meat factories. Instead, it inspired a generation of vegetarians and a host of new food safety regulations, including one that ultimately led to the creation of the Food and Drug Administration(FDA).

The Jungle - Upton Sinclair - Postcards (Pkg of 8)

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Monday, September 21, 2009

FDA Offers Warning Letter Close-Out Letter Program

According to the FDA's announcement, Warning Letter Close-Out Letter Program, the FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009. 


Saturday, September 19, 2009

Mesothelioma Awareness Day

Asbestos fibres (SEM micrograph)Image via Wikipedia

According to Mesothelioma Awareness Day Observed September 26 , "on September 26, 2009 those affected by the asbestos-related cancer mesothelioma and volunteers worldwide will help call attention to the rare cancer on national Mesothelioma Awareness Day. The Mesothelioma Applied Research Foundation, the non-profit organization that started the day in 2005, expects the day to be the most successful awareness day for the cancer since it was organized four years ago." 


Friday, September 18, 2009

Free FDA IND Education For Small Business on Oct 15 2009

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process, CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.

Date: October 15, 2009 Time: 8:00 a.m. - 5:00 p.m.

Send the registration form to CDERSmallBusiness@fda.hhs.gov. For more information contact Ron Wilson at 301-796-3177 or Brenda Stodart at 301-796-3102. There is no registration fee Space is limited to 225 participants. The FDA appreciates advance notice of cancellations or replacements. Registration on the day of the event may be possible on a space availability basis. 

Wednesday, September 16, 2009

FDA Says You Only Have 15 Days To Respond To Form 483

Updated September 7, 2021

The links broke in the original post.

You can still read about the topic here:

---  the original post follows below  ---

According to this PharmTech article, FDA Begins Enforcing Deadlines on Form 483 Responses, you have only 15 days to respond to a form 483. Be aware, this article states:

Now, however, FDA “will not ordinarily delay the issuance of a warning letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued,” according to an announcement in the Federal Register.

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Monday, September 14, 2009

10 Tips - How to Avoid FDA 483 and Warning Letters

Updated February 15, 2021

Links broke in the original post.

People also ask about:

- - -  original post follows below  - - -

It never hurts to review or re-review your policies and procedures. 

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