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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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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10 Golden Rules of GMP - Free Tips

• FDA GMP QSR cGMP Online Training - respected GMP online training courses offered by SkillsPlus International Inc.

Updated October 3, 2018

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

However, PharmOut has posted this PDF:
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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FDA Quit Smoking Resources and the Great American Smokeout

• Trusted FDA GMP online training courses and programs by SkillsPlus International Inc.

Celebrate the Great American Smokeout by checking out FDA Resources for quitting tobacco use, and more.

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Drugs and Supplements From China Still Largely Unregulated

• Pro Tip:  FDA GMP QSR cGMP Online Training - highly recommended GMP online training courses offered by SkillsPlus International Inc.

Updated February 9, 2021

Links in the original post broke.

People also ask about:

Safeguarding Pharmaceutical Supply Chains in a Global Economy - FDA.gov

- - -  original post follows below  - - -

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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