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RegisterAcute and Sub-acute toxicity studies for FDA ANDAs [Regulatives / Guidelines]
Hi Peers:
Recently one CRO asked us for sub-acute and acute study report for an injectable product. They say Indian DCGI is asking for acute and sub-acute animal studies as a condition for BE No Objections certificate for conducting a BE study. The product under consideration a product meant for US-FDA submission and it has been a FDA practice and basic understanding that non-clinical safety and clinical efficacy information is deemed established and we refer back to the approved labeling.
Is this a new requirement and how other companies handling the issue? To me the requirement seems to question age old and well understood principle.
Please advise.
Recently one CRO asked us for sub-acute and acute study report for an injectable product. They say Indian DCGI is asking for acute and sub-acute animal studies as a condition for BE No Objections certificate for conducting a BE study. The product under consideration a product meant for US-FDA submission and it has been a FDA practice and basic understanding that non-clinical safety and clinical efficacy information is deemed established and we refer back to the approved labeling.
Is this a new requirement and how other companies handling the issue? To me the requirement seems to question age old and well understood principle.
Please advise.
Complete thread:
- Acute and Sub-acute toxicity studies for FDA ANDAsAchievwin 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 ANDAs Achievwin 2024-08-27 02:42
- Acute and Sub-acute toxicity studies for FDA ANDAs NK 2024-08-06 04:06
Ing. Helmut Schütz