Tag Archive: annual report

Aug 15

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Sep 27

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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