Mailing Address for All Regulatory Submissions:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion
5901-B Ammendale Road
Beltsville, MD 20705-1266
10903 New Hampshire Ave., Building 51, Room 3203
Silver Spring, MD 20993-0002
Phone and Fax Numbers:
Fax: 301-847-8444 or 301-847-8445
For technical questions on eCTD format for CDER, please see the eCTD webpage or contact firstname.lastname@example.org. For questions regarding the draft guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising for Human Prescription Drugs (PDF) or eCTD submissions to OPDP, please contact OPDPeCTD@fda.hhs.gov.
Important Request to Industry: To facilitate our review of your promotional materials, please submit your consumer materials separately from your professional materials and identify them as such in your cover letter or FDA Form 2253.