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RegisterAcute and Sub-acute toxicity studies for FDA ANDAs [Regulatives / Guidelines]
❝ The guideline says "For all injectable, the sub-acute toxicity should be submitted on the Test product of the sponsor, studied in at least two species for minimum 14 days".
❝ This is not the new requirement.
Most un scientific requirement.... neither FDA nor EMA ask this for generic products.
Complete thread:
- Acute and Sub-acute toxicity studies for FDA ANDAs Achievwin 2024-08-05 18:50 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Acute and Sub-acute toxicity studies for FDA ANDAs NK 2024-08-06 04:06
- Acute and Sub-acute toxicity studies for FDA ANDAsAchievwin 2024-08-27 02:42
- Acute and Sub-acute toxicity studies for FDA ANDAs NK 2024-08-06 04:06
Ing. Helmut Schütz