Exhibit 1269 ยท Statute
Consolidated Appropriations Act, 2023, Pub. L. 117-328, Div. FF (Food and Drug Omnibus Reform Act of 2022), sec. 3210, Modernizing accelerated approval
The Secretary may require, as appropriate, a study or studies to be underway prior to approval, or within a specified time period after the date of approval, of the applicable product.
Section 3210 amends section 506(c) of the Federal Food, Drug, and Cosmetic Act. It lets the Secretary require a postapproval study to be underway before approval or within a specified period after approval, requires the Secretary to specify study conditions, including a target completion date, by the date of approval, and revises the withdrawal procedure.
- Source
- U.S. Congress
- Date
- 29 December 2022
- Quoted from
- Sec. 3210(a)(1)(D), new sec. 506(c)(2)(D), 136 Stat. 5822
- Grade
- Primary record
- Document
- https://www.govinfo.gov/content/pkg/PLAW-117publ328/html/PLAW-117publ328.htm
- Accessed
- 2026-11-10
- Cited by
- Findings citing this exhibit
- Note
- Approved 29 December 2022 (H.R. 2617). The quotation begins at 'The Secretary may require' inside new subparagraph (D), which is headed 'Studies begun before approval.'