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

posted by Helmut Homepage – Vienna, Austria, 2021-01-19 17:27 (91 d 04:21 ago) – Posting: # 22183
Views: 370

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
21,419 posts in 4,475 threads, 1,510 registered users;
online 5 (0 registered, 5 guests [including 1 identified bots]).
Forum time: Tuesday 22:49 CEST (Europe/Vienna)

We have to remember that what we observe is not nature herself,
but nature exposed to our method of questioning.    Werner Heisenberg

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