Postmarket Drug Safety−Related Actions Before and After the US Food and Drug Administration Amendments Act
This cross-sectional analysis found that the enhanced safety-related regulatory authorities of FDAAA were not associated with differences in time to first postmarket safety-related action. However, among therapeutics with postmarket safety-related actions within 5 years of approval, median time to first action was shorter post-FDAAA implementation.
Authors
- Reshma Ramachandran (ORCID: https://orcid.org/0000-0003-3845-3606)
- Joseph S. Ross (ORCID: https://orcid.org/0000-0002-9218-3320)
- Joshua David Wallach (ORCID: https://orcid.org/0000-0002-2816-6905)
- Molly M. Jeffery (ORCID: https://orcid.org/0000-0003-3854-6810)
- Harry Doernberg (ORCID: https://orcid.org/0000-0002-9069-2666)
- Maryam Mooghali (ORCID: https://orcid.org/0000-0001-9347-494X)
Institutions
- Mayo Clinic (US)
- Emory University (US)
- Yale University (US)
- Yale New Haven Health System (US)
- Mayo Clinic in Florida (US)
Publication Details
- Journal
- JAMA Internal Medicine
- Published
- 2025-12-08
- DOI
- https://doi.org/10.1001/jamainternmed.2025.6566
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 0.00