Office of Prescription Drug Promotion (OPDP) Launches
Please see draft guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs for recommendations on how to submit.
Please note that implementaton 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, please confirm receipt of the submission by OPDP with a phone call to the OPDP project manager at 301-796-1200.For questions regarding this information, please email CDER-OPDP-RPM@FDA.HHS.GOV.