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

posted by Helmut Homepage – Vienna, Austria, 2021-01-19 17:27 (147 d 16:00 ago) – Posting: # 22183
Views: 469

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


Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Activity
 Admin contact
21,523 posts in 4,499 threads, 1,523 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Wednesday 10:28 CEST (Europe/Vienna)

Don’t undertake a project
unless it’s manifestly important
and nearly impossible.    Edwin H. Land

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