Bioequivalence and Bioavailability Forum • Acute and Sub-acute toxicity studies for FDA ANDAs

Achievwin
★★

US,
2024-08-05 20:50
(334 d 12:01 ago)

Posting: # 24133
Views: 2,726

Acute 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.

NK
☆

India,
2024-08-06 06:06
(334 d 02:45 ago)

@ Achievwin
Posting: # 24140
Views: 2,234

Acute and Sub-acute toxicity studies for FDA ANDAs

Post reply

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 (313 d 04:09 ago) @ NK Posting: # 24162 Views: 1,794	Acute and Sub-acute toxicity studies for FDA ANDAs Post reply
	❝ 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.