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- Title
Facilitating Both Evidence and Access: Improving FDA's Accelerated Approval and Expanded Access Pathways.
- Authors
Lynch, Holly Fernandez; Bateman-House, Alison
- Abstract
The article focuses on improving the U.S. Food and Drug Administration's (FDA's) has accelerated approval and expanded access pathways. Topics inlcude the patients living with a life-threatening disease and no meaningful treatment options, the COVID-19 pandemic response is something to behold, and unapproved products have been granted Emergency Use Authorization for clinical trials have been launched at a remarkable pace.
- Subjects
UNITED States; HEALTH services accessibility laws; DRUG approval laws; HEALTH services accessibility; MARKETING; HEALTH policy; PATIENT safety; QUALITY assurance; UNITED States. Food &; Drug Administration; DRUG development; GOVERNMENT regulation; INVESTIGATIONAL drugs
- Publication
Journal of Law, Medicine & Ethics, 2020, Vol 48, Issue 2, p365
- ISSN
1073-1105
- Publication type
Article
- DOI
10.1177/1073110520935352