Bioequivalence and Bioavailability Forum • FDA guideline on BE, draft August 2021

FDA guideline on BE, draft August 2021 [BE/BA News]

posted by Helmut – Vienna, Austria, 2021-08-23 23:46 (156 d 11:02 ago) – Posting: # 22535
Views: 1,441

Hi Achievwin,

» FDA decided to split BA/BE guidance into two guidance 1) for ANDA filings and 2) for IND/NDAs

Already in 2013/2014.

» More elaborate explanations of each aspect.

I expect to see an update of #2 (current draft of Feb 2019) as well.

—
Dif-tor heh smusma 🖖
Helmut Schütz

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Complete thread:

FDA guideline on BE, draft August 2021 ElMaestro 2021-08-23 14:42 [BE/BA News]
- FDA guideline on BE, draft August 2021 Helmut 2021-08-23 15:31
  - FDA guideline on BE, draft August 2021 Achievwin 2021-09-08 04:09
    - Bias correction unveiled Helmut 2021-09-10 20:47
- FDA guideline on BE, draft August 2021 Achievwin 2021-08-23 21:35
  - FDA guideline on BE, draft August 2021Helmut 2021-08-23 23:46