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OPDP Bad Ad Program absent in 2013 and first four months of 2014

USA - April 30 2014 On May 11, 2010, the Division of Drug Marketing, Advertising, and Communications (DDMAC), now the Office of Prescription Drug Promotion (OPDP)…

OPDP issues first enforcement letter in months to pharmaceutical company for misleading patient brochures

USA - November 4 2013 On October 24, 2013, the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) issued an Untitled Letter to Sunovion…

A quick observation regarding the FDA and the Caronia decision…

USA - February 1 2013 On December 3, 2012, the United States Court of Appeals for the Second Circuit handed down its decision in U.S. v. Caronia, and ruled that the…

Sarah M. Canberg

FDA seeks comments on proposed comparative price information study

USA - May 20 2014 In a notice published in the Federal Register on May 7, 2014, the federal Food and Drug Administration (FDA) is soliciting comments on a proposed…

OPDP restructures again: promotional review by therapeutic area instead of audience

USA - March 11 2013 According to a recent FDA announcement, the Office of Prescription Drug Promotion (OPDP) is restructuring its review process. OPDP currently reviews…