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DDMAC Adds New Consumer Group To Handle Ad Load; More Marketing Briefs

Executive Summary

A fresh look at DTC: CDER's Division of Drug Marketing, Advertising & Communication is creating a second direct-to-consumer review group to address the ad division's growing review burden. "It's just important to try to address the increased workload that we're getting and to have two group leaders to help to make sure that our advisory comments to you are not getting bottlenecked somewhere," DTC Review Group Leader Melissa Moncavage says at FDLI's Sept. 18-19 advertising and promotion conference. The DTC review groups will be led by Moncavage and Lead Consumer Safety Officer Christine Smith, effective immediately. DDMAC will retain its four review groups to evaluate professional advertising. Funding to help meet DDMAC's workload, which has increased with the PhRMA guideline's recommendation for DTC preclearance, has come up in PDUFA negotiations...

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