New FDA bioavailability guidance [BE/BA News]

posted by wienui  – Germany/Oman, 2022-04-15 11:44 (789 d 21:16 ago) – Posting: # 22932
Views: 2,931

Dear All,

Yesterday, on 14 April, The US Food and Drug Administration (FDA) published final guidance on the bioavailability (BA) data drug sponsors should include in their premarket investigational new drug (IND) applications, new drug applications (NDA), and NDA supplements.

The guidance has been several years in the making after garnering significant feedback from the industry, which the agency says it has addressed in the latest version.

https://www.fda.gov/media/121311/download.

Cheers,
Osama

Complete thread:

UA Flag
Activity
 Admin contact
23,056 posts in 4,840 threads, 1,641 registered users;
80 visitors (0 registered, 80 guests [including 10 identified bots]).
Forum time: 09:01 CEST (Europe/Vienna)

Everything is trivial, if you know the answer.    Thomas Jaki

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