Tag Archive: 21 CFR

Jun 08 2012

Warning: Your “Check CAPA” Light is On

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.  How to respond to warning letters has been covered previously in this forum, but today I want to focus on one specific aspect of …

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Jun 08 2012

Warning: Your “Check CAPA" Light is On

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.  How to respond to warning letters has been covered previously in this forum, but today I want to focus on one specific aspect of …

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May 21 2012

Stem Cells: Which Way to the Clinic? (Updated!)

For over two decades, the potential of stem cell therapy to cure some of our most devastating diseases has been touted by the media.  A Google search of “stem cell research” yields over 57 million results, and yet, in mid-2012, there is only one approved stem cell product on the market in the United States …

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May 18 2011

FDA Enforcement of New IND and BA/BE Safety Reporting Requirements

FDA announced at the end of March 2011 that the new IND and bioavailability/bioequivalence (BA/BE) study reporting requirements (final rule published September 29, 2010), originally effective on March 28, 2011, will not be enforced until September 28, 2011.  FDA’s intent for the final rule was to improve monitoring of adverse events (including those from BA/BE …

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Sep 27 2010

Annual Reports: A Time for Reflection

You do something annual every year, don’t you? – George Noory Is it time stop and think over the events previous year?  Quite possibly.  In the rush to keep things moving, it’s all too easy to not take the time to pause and get a healthy dose of perspective.  Enter annual reports for drug/biologic development …

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May 17 2010

DDMAC Sends Warning Letter Over Unbranded Websites

If you judge, investigate. – Seneca I know you just read the title, but let me say it again with some emphasis:  DDMAC Sends Warning Letter Over Unbranded Websites.  That’s right, a warning letter over websites that contained no “direct” references to a product…although, as we’ll see, the indirect references were too direct for the …

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