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RegisterFDA guideline on BE, draft August 2021 [BE/BA News]
» 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.
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 [BE/BA News]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 2021-09-08 04:09
- 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
- FDA guideline on BE, draft August 2021 Helmut 2021-08-23 15:31
Ing. Helmut Schütz