What steps is FDA taking or planing to take, to collaborate with other regulatory authorities to align on expectations for Step 2 confirmatory testing?

This and more questions related to Impact and Harmonization on this document recently published by FDA from a recent FDA-Industry meeting AAM/CHPA/PhRMA May 4th

QA Written Responses_Joint Industry Group Meeting on Nitrosamines_final.pdf (133.3 KB)


Thank you for sharing.

Thanks for sharing information QA.

Continuing this valuable stream of information… I’m sharing here the Memorandum of Meeting FDA & Joint Industry Meeting.
It does contains: Attendant list, Industry presentations, Q&A report from FDA.

Memorandum of Meeting FDA - Industry Meeting May 4th 21.pdf (2.6 MB)


Thanks for sharing Naiffer @Naiffer_Host, that’s an interesting read!