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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.
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.
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Cheers,
Osama
Cheers,
Osama
Complete thread:
- New FDA bioavailability guidancewienui 2022-04-15 09:44 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- New FDA bioavailability guidance Relaxation 2022-04-16 13:59
- New FDA bioavailability guidance zizou 2022-04-16 18:22
- Excellent post! Helmut 2022-04-17 13:03
- New FDA bioavailability guidance zizou 2022-04-16 18:22
- New FDA bioavailability guidance Relaxation 2022-04-16 13:59
Ing. Helmut Schütz