FDA recommendations on BE trials during the pandemic [Regulatives / Guidelines]

posted by Ohlbe – France, 2020-04-28 23:01  – Posting: # 21358
Views: 2,121

Dear all,

The FDA has published high-level recommendations on bioequivalence studies for submission in ANDAs during the COVID-19 pandemic. Basically: it may be a mess outside (no kidding !), prioritise subjects' safety, use controlled correspondence.

Regards
Ohlbe

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