Tuesday, November 30, 2010

FDA Home Use Device Initiative

On the Designated Representative and Exemptee Blog - News On FDA Home Use Device Initiative: the FDA may suggest devicemakers create different written instructions for the patient, prescriber of the device and the person training the consumer on how to use the device.

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Tuesday, November 23, 2010

Turkey Talk - Avoid Getting Sick

Thanksgiving is here. I'm reprising one of my oldie but goodie posts, Time To Talk About Turkey Cooking and Food Safety.  Follow the link to a well written set of do's and don'ts.  As a bonus there are additional links that might pique your interest.

For fewer clicks, here's the real 'meat' of the matter:
Let's Talk Turkey—A Consumer Guide to Safely Roasting a Turkey

Enjoy your safe, and well-prepared Turkey dinner!

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Monday, November 22, 2010

10 Golden Rules of GMP - Free Tips

Updated November 18, 2016

The white paper referenced in the original post is no longer available.

However, PharmOut has this webpage now:
The 10 Golden Rules of GMP - PharmOut

- -  original post follows below  - -

This free GMP white paper from PharmOut is a great read, White Paper - The 10 Golden Rules of GMP (pdf).

You get a quick list of the 10 golden rules, an excellent explanation of each rule, and finally a self-audit checklist.

Enjoy!

#FDA #GMP #training #cGMP

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Monday, November 15, 2010

Drugs and Supplements From China Still Largely Unregulated

Probably not surprising, and certainly disappointing, as reported by this KansasCity.com news article, Drugs, supplements come to U.S. from China largely unregulated.

I'm most concerned about, "One consequence of the lack of regulation has been a rising number of counterfeit drugs."

Related links:
GAO Report Blasts FDA for Failure to Implement 2008 Recommendations

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Wednesday, November 10, 2010

Shocking FDA Images For Cigarette Packages

Wow! These are high impact and jarring images. You have to check out what the FDA is proposing as new required warnings, consisting of nine new textual warning statements accompanied by color graphics depicting the negative health consequences of smoking, Proposed FDA Graphic Health Warnings for Cigarette Packages and Advertisements (PDF).

More Information:
FDA Proposed Cigarette Product Warning Labels

Stop Smoking:
Quit Smoking Today (http://www.smokefree.gov/)
Nicoderm CQ Step 1 Clear Patch 14-pk.

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Monday, November 8, 2010

FDA GMP Books - Limited Previews

A Picture of a eBookImage via WikipediaI'm a big fan and user of many of Google's offerings. 

While wandering through Google Books, I ran across these limited previews of these three FDA GMP-related books. I thought you might be interested.  Although the previews are limited, there's certainly enough content that can be read for learning, and plenty to review if you're considering buying the book.

Interpretation of FDA's Quality System Regulations (QSR) With QSIT references By Medical Device School (Google books preview)

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Google books preview)

Good manufacturing practices for pharmaceuticals (Google books preview)

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Monday, November 1, 2010

Staying Alive - New AHA 2010 CPR Technique (video)

This is a major change.  Watch this video to learn about the American Heart Association (AHA) 2010 Guidelines for CPR.  The guidelines mention the song Stayin' Alive for the compression rate of 100 beats per minute. 



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