Nearly four months after a White House review cleared the document for release, the FDA today unveiled a final guidance meant to recommend how companies should present quantitative information about the risks and effectiveness of a drug in direct-to-consumer advertising. Industry should take note of some of the consequential changes in the final guidance, including those related to the presentation of information about control groups, which will likely apply to many drug advertisements.
Regulatory background
The FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) regulates pharmaceutical advertising in the U.S., including direct-to-consumer advertising.
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