New FDA bioavailability guidance [BE/BA News]

posted by wienui  – Germany/Oman, 2022-04-15 11:44 (735 d 00:08 ago) – Posting: # 22932
Views: 2,675

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

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