Bioequivalence and Bioavailability Forum

Ohlbe ★★★ France, 2020-04-28 23:01 (372 d 01:09 ago) Posting: # 21358 Views: 2,565	FDA recommendations on BE trials during the pandemic [Regulatives / Guidelines] Post reply
	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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FDA recommendations on BE trials during the pandemic [Regulatives / Guidelines]