Assessing US Food and Drug Administration Guidance Practices in Drug Development
This Viewpoint discusses the US Food and Drug Administration’s history of guidance documents, trends in publishing practices, and suggested reforms for further improvements.
Authors
- G. Caleb Alexander (ORCID: https://orcid.org/0000-0002-5622-2986)
- Peter Lurie (ORCID: https://orcid.org/0000-0001-7867-4951)
- Joseph T. Kannarkat
Institutions
- Center for Science in the Public Interest (United States) (US)
- Johns Hopkins University (US)
- Johns Hopkins Medicine (US)
Publication Details
- Journal
- JAMA Health Forum
- Published
- 2025-05-23
- DOI
- https://doi.org/10.1001/jamahealthforum.2025.1124
- Primary Topic
- Pharmaceutical Economics and Policy
- Type
- article
- Field-Weighted Citation Impact
- 0.00