CMC Information Generally Not Needed at the Time of FIH Phase 1 IND (For DS and DP): Risk assessments for elemental impurities and nitrosamine impurities are not expected.
cder-regulated_small_molecule_drug_products_cmc_ind_table (1).pdf (172.8 KB)
5 Likes
I found the context of this document. It is linked from the page titled “IND Applications for Clinical Investigations: Chemistry, Manufacturing, and Control (CMC) Information.”
FDA provides regulatory flexibility to support bringing innovative treatments to patients as quickly as possible. By focusing on minimum requirements to ensure phase-appropriate CMC information is provided, FDA estimates that sponsors of FIH Phase 1 INDs can reduce application development time by up to 12 months.
2 Likes
Interesting. I’ve been a part of multiple debates on this. I would say that best practice would be to at least identify your vulnerable amines so you’re not surprised later & can build scavengers into the plan early, if the need is likely.
2 Likes