Monday, January 25, 2010

FDA to Enforce OTC Labeling Requirements in September 2010

The FDA News reports that as of September 2010 the FDA will begin enforcing requirements that over the counter drug manufacturers must include domestic contact information for patients to use to report serious adverse events associated with use of the product on the labeling. The rule has been in effect since 2007, but the FDA has not been uniformly enforcing it until now.

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