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- Title
The Curious Case of Off-Label Use.
- Authors
Dresser, Rebecca
- Abstract
The article discusses the process of approving new drugs and devices for safety and effectivity by the U.S. Food and Drug Administration (FDA). Off-label prescribing of medical products occurs when clinicians give products to people with conditions not listed on the approval label and when they depart from the approved drug dosage, method of administration or patient population. The FDA should regulate off-label use by methods that differ from the rules governing initial product use.
- Subjects
UNITED States; DRUG labeling; DRUG administration; MEDICAL prescriptions; UNITED States. Food &; Drug Administration
- Publication
Hastings Center Report, 2007, Vol 37, Issue 3, p9
- ISSN
0093-0334
- Publication type
Article
- DOI
10.1353/hcr.2007.0039