About FDA

Contact OPDP

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

Office Location:

10903 New Hampshire Ave., Building 51, Room 3203
Silver Spring, MD 20993-0002

Phone and Fax Numbers:

Phone: 301-796-1200
Fax: 301-847-8444 or 301-847-8445

White Oak Maps


For technical questions on eCTD format for CDER, please see the eCTD webpage or contact esub@fda.hhs.gov.  For questions regarding the draft guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising for Human Prescription Drugs (PDF) or eCTD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.

Page Last Updated: 06/03/2015
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