FDA to Enforce OTC Labeling Requirements in September 2010

The FDA will begin enforcing requirements for adverse event reporting information on the labeling of most OTC drugs without approved applications next year, according to a final guidance. Marketers of the drugs must include domestic contact information for patients to use to report serious adverse events associated with use of the product on the labeling, the guidance says. The labeling requirement took effect in 2007, but the FDA says it will exercise its discretion in enforcement until Sept. 30, 2010.
Drug Industry Daily