Support for Clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program

CBER Rare Disease Program Rare diseases and conditions as defined by the Orphan Drug Act (1983) affect

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Artificial Intelligence and Machine Learning for CBER Regulated Products

Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER Artificial

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CBER Product Approval Information

This list includes applications for which we have approval documents available, and reflects the information

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