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RegisterFDA recommendations on BE trials during the pandemic [Regulatives / Guidelines]
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.
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.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- FDA recommendations on BE trials during the pandemicOhlbe 2020-04-28 23:01 [Regulatives / Guidelines]
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Ing. Helmut Schütz