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

posted by Ohlbe – France, 2020-04-28 23:01 (355 d 18:41 ago) – Posting: # 21358
Views: 2,539

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

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 6 (0 registered, 6 guests [including 1 identified bots]).
Forum time: Monday 17:42 CEST (Europe/Vienna)

There is one certainty in drug development
and statistics that one can depend on:
the data are always late.    Scott Patterson and Byron Jones

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5