U.S. FDA Releases Draft Guidance on Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics (Part 2.)
- Evidentiary Criteria for Accelerated Approval
Drugs under accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval. Applicants must provide adequate evidence demonstrating that the proposed surrogate or intermediate clinical endpoints are reasonable and predictive of the intended clinical benefit. FDA evaluates this using empirical data, including epidemiological, pathophysiological, therapeutic, and clinical evidence.
- Confirmatory Trials
For drugs granted accelerated approval, sponsors are required to complete post-approval confirmatory trials to validate clinical benefits. They must submit detailed trial plans and adhere to the specified timelines. If trials have not started by the time of approval, they must commence immediately. For rare diseases or challenging recruitment scenarios, FDA may permit alternative approaches, such as trials in related patient populations or extended studies using the same surrogate endpoint. Additionally, FDA encourages incorporating patient perspectives into trial design to improve recruitment and retention, particularly in rare disease populations.
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