OPDP advises industry to focus on voluntary compliance in 2012


The FDA’s Office of Prescription Drug Promotion (OPDP) officials noted in a late December enforcement webinar that companies should address some of the common problem areas cited in recent OPDP enforcement letters. Companies should review “our enforcement actions, guidance and regulations” as well as submit materials for advisory comments as part of their voluntary compliance efforts, according to OPDP Regulatory Counsel Julie Chronis. She indicated that OPDP is not “off on a witch hunt” but instead is “looking for companies to do the right thing.” Read more.

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