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FDA to Enforce OTC Labeling Requirements in September 2010

September 1, 2009

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 independently of approved applications next year, according to a final direction. Marketers of the drugs must include domestic contiguity complaint for patients to exercise to describe serious adverse events associated with use of the production on the labeling, the guidance says. The labeling requirement took effect in 2007, but the FDA says it will exercise its judiciousness. in enforcement till Sept. 30, 2010.

Written by Samanta · Filed Under FDA News