Tag Archive: product safety

PV / Drug Safety Crises

Bart’s Corner: PV Crises

This is a follow up to the previous posting on PV Stress Tests. During every PV person’s career, a “PV crisis” will arise. PV “crises” can occur in clinical trials or during marketing and may be of varying degree and type; so let’s define them first. Although the following are[…]

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Generic Safety Labeling: FDA’s new regulation – Part 1

On November 8, 2013 FDA published an announcement in the Federal Register regarding new labeling requirements for generic drugs.  (See https://telerx.bz/3n) It was officially published November 13, 2013.  There will be a 60 day comment period and then, presumably, FDA will make the regulations final and they will take effect –[…]

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