FDA's New Plausible Mechanism Pathway
N Engl J Med
.
2025 Dec 11;393(23):2365-2367.
doi: 10.1056/NEJMsb2512695.
Epub 2025 Nov 12.
Authors
Vinay Prasad
1
,
Martin A Makary
2
Affiliations
1
Food and Drug Administration, Office of the Director, Center for Biologics Evaluation and Research, Silver Spring, MD.
2
Food and Drug Administration, Office of the Commissioner, Silver Spring, MD.
PMID:
41223362
DOI:
10.1056/NEJMsb2512695
No abstract available