US Code

Public Law 119-73 (01/23/2026)

21 U.S.C. § 356–2

Accelerated approval Council

(1)

In general

section 356(c) of this titleNot later than 1 year after , 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 .

(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;
(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 , 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)136 Stat. 5824(, , .)

Editorial Notes

Codification

Section was enacted as part of the Food and Drug Omnibus Reform Act of 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Construction

section 3210(e) of Pub. L. 117–328section 356(c) of this titlesection 3210(f) of Pub. L. 117–328section 356 of this titleNothing in , which enacted this section, to be construed to affect ongoing withdrawal proceedings for products approved pursuant to for which a notice of proposed withdrawal has been published in the Federal Register prior to , see , set out as a Construction of 2022 Amendment note under .

Definition of “Secretary”

section 3002 of div. FF of Pub. L. 117–328section 350a–1 of this titleSecretary as used in this section means the Secretary of Health and Human Services, see , set out as a note under .