Deadline for reporting changes

Guidance, Documents, Resources
1

For US FDA deadline for reporting changes for approved and marked product for small molecule nitrosamine was within 3 years of publication of the original guidance that was on or before October 1, 2023 which is expired now.

Also, implementation timelines for NDSRIs for approved and marked product is by August 1, 2025.

Many drugs product have both small as well as NDSRIs. Considering risk assessment is product specific can we consider August 1, 2025, as final deadline for the drug product.

2

Yes, we can consider it as final timeline for the detailed risk assessment.

3

Thanks for your reply.