Phase 1 IND Chemistry, Manufacturing, and Controls Flexibilities
Phase 1 IND Navigator | Expert Resources. Trusted Support.
FDA provides regulatory flexibility to support bringing innovative treatments to patients as quickly as possible. FDA recently clarified the minimum CMC information that sponsors of FIH Phase 1 INDs should submit and what information can generally be submitted at later stages of development. 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.
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Questions? Contact the Phase 1 Clinical Trials Support Team:
Phone: 240-276-9358
Email: Phase1Questions@fda.hhs.gov