FDA: ANDA during COVID-19 pandemic [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2021-01-19 18:27 (1134 d 10:17 ago) – Posting: # 22183
Views: 1,138

Dear all,

last Friday the FDA’s CDER/OGD published a new guidance

Protecting Participants in
Bioequivalence Studies for
Abbreviated New Drug
Applications During the COVID-19
Public Health Emergency


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