21 USC 356-2 - Accelerated approval Council

U.S Code last checked for updates: Nov 22, 2024

§ 356–2.

Accelerated approval Council

(1)

In general

(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

(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

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

cite as: 21 USC 356-2