FDA’s Rx Enforcement Letter Output Drops In 2011; OPDP Sees Improvement In Promotions
The 30 letters issued are the lowest since 2008, but FDA says the number is only part of its enforcement strategy.
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FDA advises companies to respond to unsolicited requests for off-label information in one-on-one dialogue; the agency also requests public comments on its policies regarding off-label communications in response to an industry citizen petition.
Certain drug classes will be required to submit certain types of ads, according to Tom Abrams, director of CDER’s recently elevated Office of Prescription Drug Promotion, but specifics will await the guidance itself.
Website suggested that the unapproved cancer immunotherapy was safe and effective, FDA says.