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Home » FDA Guidance Advises RCTs for Oncology Drugs Seeking Accelerated Approval
FDA Guidance Advises RCTs for Oncology Drugs Seeking Accelerated Approval
Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance issued last week.