Regulatory Matters

ISPE’s Drug Shortages Prevention Plan Task Team Chair provides insight on the Team’s Approach

François Sallans, Chair of the ISPE Drug Shortages Task Team, is interviewed about ISPE’s Drug Shortage Prevention Plan in the September/October 2014 issue of Pharmaceutical Engineering.  In the interview,...
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FDA Draft Guidance for Industry: Content and Format of Abbreviated New Drug Applications

FDA published a notice in the Federal Register announcing the availability of a draft guidance for industry, entitled ANDA Submissions–Content and Format of Abbreviated New Drug Applications. On July...
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