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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…

Untruthful or misleading prescription drug promotion, the subject of OPDP new e-learning course

USA - October 30 2013 In May 2010, the the Food and Drug Administration's (FDA) Office of Prescription Drug Promotion(OPDP) (formerly the Division of Drug Marketing…

First half of 2013: ten FDA enforcement letters

USA - July 15 2013 The Office of Prescription Drug Promotion ("OPDP") of the Federal Drug Administration ("FDA") issued ten enforcement letters in the first six months…

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…

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.