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Direct-to-Consumer (DTC) Television User Fee Program Documents
If you have questions about the DTC user fee program or about submitting DTC TV ads for advisory review, please contact either Mr. Wayne Amchin or Mr. Paul Loebach at (301) 796-1200. Proposed DTC TV Advertisements Voluntarily Submitted for DDMAC Advisory Review Since the DTC User Fee Program will not be implemented, all direct-to-consumer (DTC) television advertisements voluntarily submitted for DDMAC advisory review should be sent directly to FDA’s central document room to the attention of DDMAC’s Project Management Team. Please send these submissions to: Wayne Amchin DDMAC strongly encourages companies to note on the exterior package that the submission is a proposed DTC TV ad for DDMAC advisory review. Companies with questions about submission of proposed DTC TV advertisements should contact Wayne Amchin or Paul Loebach at 301-796-1200 or by email at dtcp@fda.hhs.gov. Companies planning to send more than one proposed DTC television advertisement to DDMAC for advisory review should not consolidate them into one submission. Each proposed DTC television advertisement for advisory review should be submitted separately (not bundled together), and each submission should be complete and reviewable as a stand-alone submission. What Constitutes a Complete and Reviewable DTC TV Submission? Please visit DDMAC’s submission page for information on what constitutes a complete and reviewable DTC TV submission, and for information on other submissions. DDMAC’s submissions web page is available at http://www.fda.gov/cder/ddmac/submissions.htm. Federal Register Documents Concerning the DTC User Fee Program
Date created: October 1, 2007, Last updated: February 21, 2008 |
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