Happy Thanksgiving - Celebrate These Food Safety Tips

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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!

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• NYT: E. coli path shows beef inspection flaws (msnbc.msn.com)
• Tainted Food Surprisingly Deadly in Adults: WHO (nlm.nih.gov)
• Advice on the safety of ground meat (timesunion.com)

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FDA Draft Guidance on Anti-Counterfeiting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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• Mounties bust Montreal counterfeit pharmaceuticals network (canadianmedicinenews.com)
• Africa's fake pharmaceuticals problem (telegraph.co.uk)
• A New War on Drugs: Stopping The Counterfeit Medicine Trade (time.com)

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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

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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.

Previous Posts:
Rx-360 - A non-profit to help secure the supply chain (podcast)
FDA On Drug Counterfeiting

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• Dietary supplement adulteration with prescription drugs: Is it really a problem of DSHEA? (scienceblogs.com)

AMA Unveils Flu Assessment Tool

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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.

Previous Posts:
FDA Search Widget of Fraudulent H1N1 Products
Got Wine Flu?
Flu.gov Updated by HHS - New Resources Added

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• Resistance to flu shots violates nurses' duty (timesunion.com)
• Obama declares H1N1 emergency (cnn.com)
• 1 in 5 U.S. kids had flu this month (msnbc.msn.com)

FDA FAQ On IV Peramivir To Treat H1N1 Flu

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.

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• Peramivir for H1N1 (emergency use only) (medicineandtechnology.com)

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

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• Gray Sheet: CDRH Director Resigning Amidst Controversy (invivoblog.blogspot.com)
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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.

These are some of the areas the online courses cover:
Overview of Regulatory Requirements: Medical Devices
Quality System Regulation 21 CFR Part 820 Basic Introduction
Device Establishment Registration and Listing
Overview of the Premarket Notification Process – 510(k)
How to Get Your Electronic Product on the U.S. Market
Bioresearch Monitoring (BIMO)
Future Course Topics

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• 501(k) to be evaluated by the IOM (medicineandtechnology.com)
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FDA And Others To Study Lasik Problems

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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?

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• FDA Announces Plans for LASIK Quality of Life Project (fda.gov)

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

Previous Posts:
FDA Search Widget of Fraudulent H1N1 Products
Got Wine Flu?
Flu.gov Updated by HHS - New Resources Added

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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.

Previous Posts:
GMP Training Tree - Trainers, formats, methods, etc.
Try This GMP Training Tip To Start The New Year (free)
WHO Basic GMP Training Modules (free)
FDA CDRH Online Courses (Free)
Free WHO Training Guide To GMP Requirements
Free GMP Training Tips - Follow adult learning principles
Free GMP Glossary
GMP Olympics - an onsite training experience

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• Team Building For An FDA Inspection - The Employee Review (slideshare.net)

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.

Previous Posts:
2009 Pharmaceutical Trends

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• U.S. Drug Sales Projected to Rise 5% This Year* (blogs.wsj.com)
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Obese To Pay More For Health Insurance - Controversy (video)

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?

Visit msnbc.com for Breaking News, World News, and News about the Economy

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FDA Search Widget of Fraudulent H1N1 Products

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 heighth 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!

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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FDA Releases Hearing Aids Guide Online

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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.

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