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Dear all,
Well, that's not the fist time they do this while a topic is being discussed at ICH level (marking their territory ? Trying to give more strength to their positions during negotiations ?). Anyway, the FDA have published last week two new final guidances:
- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA: see here
- Statistical Approaches to Establishing Bioequivalence: see here.
Well, that's not the fist time they do this while a topic is being discussed at ICH level (marking their territory ? Trying to give more strength to their positions during negotiations ?). Anyway, the FDA have published last week two new final guidances:
- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA: see here
- Statistical Approaches to Establishing Bioequivalence: see here.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- New FDA guidancesOhlbe 2026-06-01 17:04 [Regulatives / Guidelines]
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Ing. Helmut Schütz