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RegisterFDA PSGs: Alternative approach [Design Issues]
posted by Helmut 
– Vienna, Austria, 2025-02-20 11:44 (486 d 03:26 ago) – Posting: # 24366
Views: 5,738
Hi John,
as usual in the FDA’s guidances:
as usual in the FDA’s guidances:
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Office of Generic Drugs.
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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
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Ing. Helmut Schütz