Regulatory Flexibilities and Clarifications: Chemistry, Manufacturing and Control (CMC) Information for Original First in Human (FIH) Phase 1 INDs

Guidance, Documents, Resources
1

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)

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