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

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

posted by Achievwin – US, 2021-08-23 23:35 (651 d 21:33 ago) – Posting: # 22534
Views: 2,302

❝ FDA updated the canonical BE guideline for ANDAs. Draft. :-)

Comments period is open till October 22, 2021, Therefore any issues bothering/benefit ANDA folks can be sent to FDA as comments for consideration.

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

More elaborate explanations of each aspect.

Complete thread:

FDA guideline on BE, draft August 2021 ElMaestro 2021-08-23 14:42
- 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 2021Achievwin 2021-08-23 21:35
  - FDA guideline on BE, draft August 2021 Helmut 2021-08-23 23:46