OPDP Submission of Proposed Direct-to-Consumer (DTC) TV Ads for Advisory Review
Please see draft guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs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.
Companies with questions about submission of proposed DTC TV advertisements should contact OPDP at 301-796-1200 and ask to speak to a Project Manager or the relevant reviewer.