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The Greatest FDA Advisory Committees, Part II: The Birth Of The ‘Pazdur Moment’

 
• By Ramsey Baghdadi

With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years. This is Part II in the series.

Gypsum Statue of Giuliano de' Medici
This isn't actually Richard Pazdur; it's Giuliano de Medici

The upcoming advisory committee reviews of the first coronavirus vaccine(s) and Biogen, Inc.’s aducanumab for Alzheimer’s should be two historic panel meetings, prompting a look back at the greatest FDA advisory committees of the last 20 years. (Here’s Part I.)

For the Part II in the series, we focus on one committee meeting because it deserves special attention: two-in-one reviews...

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Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

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• By Bridget Silverman

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US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

More from Regulatory Trackers

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

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• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.