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
OPDP protects the public health by helping to ensure that prescription drug information is truthful, balanced, and accurately communicated. This is accomplished through comprehensive surveillance, compliance, and education programs, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers.
Update on non-eCTD Submissions to OPDP
Recognizing that some submissions will be exempt from the eCTD requirement (i.e. Advisory Submissions, Amendments, Response to Information Requests, etc), CDER is providing an alternate electronic submission pathway to sponsors or applicants. OPDP encourages submissions to be made electronically via CDER NextGen Portal for submissions covered under such exemptions rather than paper or physical media.
For information on how to organize a submission covered under such exemptions, please refer to the Providing Regulatory Submissions in Alternate Electronic Format; Draft Guidance for Industry. Please note the draft guidance says to submit via ESG, however, CDER has since opened the CDER NextGen Portal to accept these submissions as well.
For additional information on the promotional submissions which will be exempt from eCTD submission requirements and the contents of those submissions, please refer to the Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs; Final Guidance for Industry.
Any questions related to the submission promotional materials to CDER may be directed to OPDPeCTD@fda.hhs.gov
FDA Issues Guidance for Industry: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers
On February 03, 2020, FDA issued a draft guidance for industry entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers.” This guidance provides manufacturers, packers, distributors, and their representatives with information to consider when developing FDA-regulated promotional labeling and advertisements (promotional materials) for prescription reference and biosimilar products licensed under the Public Health Service Act. Although the guidance covers promotional issues involving both reference and biosimilar products, some questions and answers are focused on only biosimilar product promotional materials. The guidance does not discuss considerations unique to promotional materials for interchangeable biosimilars. For more information about the guidance, see the Notice of Availability
The Office of Prescription Drug Promotion (OPDP) reminds you to use the current Form FDA-2253 [PDF] and instructions [PDF]. Visit the OPDP Form FDA-2253 and Request for Advisory Comment Submissions page for additional information.
If you have problems opening a PDF form in your browser, try downloading it instead:
- Right-click the form link.
- Click the Save option. (On most browsers, this is the Save Link As option)
You may also need to upgrade your version of Adobe Reader.
Information About What OPDP Reviewers Do
OPDP reviewers have responsibility for reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading. They engage in a variety of tasks to perform this responsibility, including: providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion; reviewing complaints about alleged promotional violations; initiating enforcement actions on promotional materials that are false or misleading; comparing the product labeling and promotional materials of various closely related products to ensure that the regulatory requirements are consistently and equitably applied; traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities; and acting as a liaison between OPDP and other divisions within the FDA on promotional issues.
Providing Regulatory Submissions in Electronic and Non-Electronic Format
Please see the guidance (PDF) for information on electronic (including eCTD) and non-electronic submissions. FDA is expected to begin accepting eCTD submissions using the new M1 specifications as of June 15, 2015. Please refer to the eCTD webpage for details.
For technical questions on eCTD format for CDER, please refer to the eCTD webpage or contact firstname.lastname@example.org. For questions regarding the guidance or eCTD submissions to OPDP, please contact OPDPeCTD@fda.hhs.gov.
Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)
The Prescriber's Role - Recognize and Report
FDA's educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.
The "Bad Ad" Program is administered by the agency's Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.
OPDP Submission Information
- OPDP Form FDA 2253 and Request for Advisory Comment Submissions
- OPDP Complaints
- Electronic (including eCTD) and Non-Electronic Submissions
- OPDP Frequently Asked Questions (FAQs)
- For Industry: Using Social Media
- OPDP Research
- OPDP Organization Listing
- Contact OPDP
- OPDP Regulatory Information
- Truthful Prescription Drug Advertising and Promotion
- OPDP Metrics
- OPDP eCTD