Home » FDA Guidance Details Process for Breakthrough Therapy Designation
FDA Guidance Details Process for Breakthrough Therapy Designation
The FDA issued a long-awaited guidance Tuesday outlining how pharma companies can receive a breakthrough therapy designation for a new drug, opening a door to faster approval. The designation, mandated in the FDA Safety and Innovation Act, is reserved for drugs that treat a serious, life-threatening condition.
Drug Industry Daily
Drug Industry Daily
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