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.
Notes
Dresser, Rebecca; Source Info: May/Jun2007, Vol. 37 Issue 3, p9; Subject Term: DRUGS; Subject Term: DRUGS -- Administration; Subject Term: MEDICINE -- Formulae, receipts, prescriptions; Subject Term: LABELING; Subject Term: UNITED States; Company/Entity: UNITED States. Food & Drug Administration; Number of Pages: 3p; Document Type: Article
