§356–2 Accelerated Approval Council

Summary

Not later than 1 year after December 29, 2022, the Secretary must create an internal FDA group called the Council. The Council must make sure the FDA uses accelerated approval in a consistent and appropriate way. Its members must include senior directors from key FDA centers and offices (Drug Evaluation and Research; Biologics Evaluation and Research; the Oncology Center of Excellence; the Office of New Drugs; the Office of Orphan Products Development; the Office of Tissues and Advanced Therapies; the Office of Medical Policy) and at least 3 review-division directors who oversee accelerated-approval products, including at least one from the Office of Neuroscience. The Council must meet at least 3 times per calendar year. It must work with product review teams to support consistent use of accelerated approval. That work can include creating guidance and best practices, training review teams, and advising on product development, review, or withdrawal under accelerated approval. Not later than 1 year after December 29, 2022, and annually thereafter, the Council must post a report about its activities on the FDA public website.