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RegisterFDA guideline on BE, draft August 2021 [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2021-08-24 01:46 (1117 d 21:56 ago) – Posting: # 22535
Views: 3,376
Hi Achievwin,
Already in 2013/2014.
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.
—
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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