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Regulatory Focus™ > News Articles > It’s the Law: Issued Less Frequently, DDMAC Letters Still Offer Valuable Lessons

It’s the Law: Issued Less Frequently, DDMAC Letters Still Offer Valuable Lessons

Posted 01 July 2008

Drug companies are wise to review promotion deemed violative by the Food and Drug Administration's Division of Drug Marketing, Advertising and Communication (DDMAC) to better evaluate their own promotional materials. Such a review provides valuable guidance about the types of claims that are "high risk" and likely to garner unwelcome scrutiny from the federal government. This article provides an overview of the five Warning Letters and four Untitled Letters1 from DDMAC during the last half of 2007, as well as the sole Warning Letter issued in the first calendar quarter of 2008.

 

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