US FDA Plans Labeling Changes On The Internet

4 November 1996

From end-November, the US Food and Drug Administration plans to provide monthly summaries of safety-related labeling changes for drug products through a MedWatch Internet site, reports the Pink Sheet.

The summaries, which will also be distributed to the 100-plus health professional organizations involved in the Med-Watch Partners program, will list the drug's brand and generic names and the sections of labeling where changes have been made, and describe the changes. Health professionals will be referred to the manufacturer for full details.

Meantime, Glaxo Wellcome may develop a US-based Web site, alongside its existing UK site, in order to reassure the FDA about its ability to regulate its presence on the Internet, notes the Pink Sheet. The GW Web site now includes no product-specific information, as this is prohibited under UK law on the grounds that it could be deemed promotional.

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