DDMAC regulatory letters could double in 2010 by ProQuest


New Year's eve is four months away, but FDA letter-writers have already been prolific in 2010 on themes of risk omission, inflated efficacy claims, and unfair balance presentation as seen in promotional materials targeting physicians and consumers. By late July, FDA's Division of Drug Marketing, Advertising, and Communications had sent out 40 enforcement letters in 2010, compared with a total of 41 enforcement letters in all of 2009, according to Karen Mahoney, an FDA spokesperson. Typically, Warning Letters are more severe than Untitled Letters, although both types usually ask that recipients immediately cease the dissemination of violative promotional materials.

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