New FDA bioavailability guidance [BE/BA News]

posted by wienui  – Germany/Oman, 2022-04-15 11:44 (1032 d 17:24 ago) – Posting: # 22932
Views: 4,069

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
23,379 posts in 4,913 threads, 1,661 registered users;
270 visitors (0 registered, 270 guests [including 19 identified bots]).
Forum time: 04:08 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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