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Requests for Advisory Comment on Promotional Materials Other than Proposed Direct-To-Consumer (DTC) TV Ads

Please see draft guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs for information on how to submit.  Please note that implementation for the new eCTD M1 is still pending.  Please refer to the ectd webpage for details and timing of implementation.


Note: For any time-sensitive materials other than proposed DTC TV advertisements, please confirm receipt of the submission by OPDP with a phone call to the relevant OPDP reviewer or the OPDP project manager at 301-796-1200. To confirm receipt of DTC TV advertisements submitted for advisory review, contact the OPDP project manager at 301-796-1200 or by email at CDER-OPDP-RPM@fda.hhs.gov.

Page Last Updated: 04/21/2015
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