21 USC 356 - Accelerated approval Council

View all text of Part A [§ 351 - § 360n-2]

§ 356–2. Accelerated approval Council

(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.

(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;

(ii) providing training for product review teams; and

(iii) advising review divisions on best practices with respect to product-specific development, review, and withdrawal of products under accelerated approval.

(4) Publication of a report

Not later than 1 year after December 29, 2022, and annually thereafter, the Council shall publish on the public website of the Food and Drug Administration a report on the activities of the Council.

(Pub. L. 117–328, div. FF, title III, § 3210(e), Dec. 29, 2022, 136 Stat. 5824.)