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Regularly Updated Drug Product Safety Information on the Internet
JAMA. 1999;281:1580.
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MEDWATCH, the FDA Medical Products Reporting Program, provides an easily accessible mechanism through its Web site on the FDA home page for physicians to learn of new safety information that has been added to the labeling. Monthly compilations of labeling changes related to drug safety, with alphabetical drug product name listings and annual indices, are found at http://www.fda.gov/medwatch/safety.htm. The available information covers July 1996 to the present.
When a drug is approved, the labeling (package insert) is the product of an intensive collaborative effort between the sponsor and the FDA to accurately reflect the state of knowledge of the drug at that time and the basis for determining it to be safe and effective for marketing for a specific indication or indications. Clinical trials described in the initial labeling provide information on a drug's safety at the time of approval. Once a product is marketed and widely used, a . . . [Full Text of this Article]
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