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RegisterFDA guideline on BE, draft August 2021 [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2021-08-23 23:46 (308 d 05:25 ago) – Posting: # 22535
Views: 1,830
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.
» 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 🖖![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
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 2021 Achievwin 2021-08-23 21:35
- FDA guideline on BE, draft August 2021Helmut 2021-08-23 23:46
- FDA guideline on BE, draft August 2021 Helmut 2021-08-23 15:31
Ing. Helmut Schütz