Achievwin ★★ US, 2024-08-05 20:50 (93 d 13:11 ago) Posting: # 24133 Views: 1,141 |
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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. |
NK ☆ India, 2024-08-06 06:06 (93 d 03:54 ago) @ Achievwin Posting: # 24140 Views: 974 |
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Hi Achievwin, ❝ 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. As per the Indian Regulatory requirement, for getting NOC for conducting BA/BE studies of Injectable product, applicant should submit sub-acute toxicity study. 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". ❝ 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. This is not the new requirement. Regards NK |
Achievwin ★★ US, 2024-08-27 04:42 (72 d 05:18 ago) @ NK Posting: # 24162 Views: 573 |
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❝ 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. |