21 U.S.C. § 356-2 Accelerated Approval Council

• Library: United States Statutes
• Edition: prefLabel,label,title,shortLabel
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)
• Citation: 21 U.S.C. § 356-2

(1) In general

Not later than 1 year after December 29, 2022, the Secretary shall establish an intra-agency coordinating council (referred to in this subsection as the "Council") within the Food and Drug Administration to ensure the consistent and appropriate use of accelerated approval across the Food and Drug Administration, pursuant to section 356(c) of this title.

(2) Membership

The members of the Council shall consist of the following senior officials, or a designee of such official, from the Food and Drug Administration and relevant Centers:

(A) The Director of the Center for Drug Evaluation and Research.

(B) The Director of the Center for Biologics Evaluation and Research.

(C) The Director of the Oncology Center of Excellence.

(D) The Director of the Office of New Drugs.

(E) The Director of the Office of Orphan Products Development.

(F) The Director of the Office of Tissues and Advanced Therapies.

(G) The Director of the Office of Medical Policy.

(H) At least 3 directors of review divisions or offices overseeing products approved under accelerated approval, including at least one director within the Office of Neuroscience.

(3) Duties of the Council

(A) Meetings

The Council shall convene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-disciplinary approaches related to product review with respect to accelerated approval.

(B) Policy development

The Council shall directly engage with product review teams to support the consistent and appropriate use of accelerated approval across the Food and Drug Administration. Such engagement may include-

(i) developing guidance for Food and Drug Administration staff and best practices for, and across, product review teams, including with respect to communication between sponsors and the Food and Drug Administration and the review of products under accelerated approval;