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- Title
FDA and the Marketplace of Ideas for Medical Products.
- Authors
Cortez, Nathan
- Abstract
The market can produce skewed information about investigational products awaiting FDA approval. But the FDA rarely steps in to correct such misleading information, despite statutory authority to do so. This article evaluates a recommendation by the FDA Transparency Working Group that FDA more clearly signal when and how it will correct misleading information about investigational products, and why such a recommendation is particularly important after the 21st Century Cures Act.
- Subjects
DRUG approval; UNITED States. Food &; Drug Administration; MARKETING ethics; INFORMATION resources management; MEDICAL ethics; PATIENT safety; PRIVACY; REPORT writing; RESPONSIBILITY; DRUG development; DISCLOSURE
- Publication
Journal of Law, Medicine & Ethics, 2017, Vol 45, p39
- ISSN
1073-1105
- Publication type
Article
- DOI
10.1177/1073110517750619