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!

Previous Posts:
EPA Attacks Nasty Bed Bugs!
College Students - eccch, dorm room bedbugs! (video)

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• Bed bugs may soon spread to transit, theatres (network.nationalpost.com)

Looking Ahead to Pharma 2010 - Through the IBM innovation lens

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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).

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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.

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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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• Google's Pitch to FDA for Online Drug Ads (blogs.wsj.com)
• Google Unveils New Pharma Ads (pharmexec.com)

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