Exhibit 100 ยท Draft guidance
Accelerated approval and considerations for determining whether a confirmatory trial is underway (draft guidance)
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.
Draft guidance that, when finalized, will describe FDA's interpretation of when a confirmatory trial is 'underway' under the authority granted by the Consolidated Appropriations Act, 2023, under which FDA may require a confirmatory trial to be underway before accelerated approval or within a specified period afterward. The page is marked 'Draft. Not for implementation. Contains non-binding recommendations'; its content is current as of 6 January 2025.
- Source
- U.S. Food and Drug Administration
- Date
- January 2025
- Quoted from
- FDA guidance page (Oncology Center of Excellence, January 2025, docket FDA-2024-D-3334), summary paragraph, quoting section 506(c) as amended by the CAA 2023
- Grade
- Primary record
- Document
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accelerated-approval-and-considerations-determining-whether-confirmatory-trial-underway
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit