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U.S. Department of Health and Human Services

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Requests for Advisory Comment on Promotional Materials Other than Proposed DTC TV Ads

Advisory comments can be requested on draft promotional pieces. Comments will be provided on claims or presentations that have not been published or disseminated and are not currently in use. If the majority of the claims or presentations in a piece have previously been published or disseminated, OPDP may choose not to provide advisory comments on the piece. With the exception of draft DTC TV ads, draft promotional materials submitted for advisory comment can be bundled together into one submission. We suggest that these materials be consolidated into single submissions to the extent possible rather than sending the materials piecemeal in several submissions over the course of a few days/weeks. However, please submit professional and consumer materials separately. This approach will help to ensure that the proposals are reviewed in a timely manner. Materials should be provided as a hardcopy in triplicate unless otherwise specified. Please do NOT include Form FDA-2253 or 356H. 

Please include in the submission:
  • Cover letter stating your request for advisory comments, contact name, title, address, phone, fax, and email of the person that OPDP should contact about issues related to the submission
  • Include "Request for Advisory Comments" in the subject line of the cover letter
  • Draft promotional materials including annotations to references
  • Annotated supporting references
  • Annotated current Approved Package Insert/Medication Guide/Patient Package Insert
  • List each promotional material individually on the cover letter
  • Include the material type (i.e. 2253 code) for each piece in parenthesis on the cover letter. The list of codes is listed in the 2253 form.
These submissions to OPDP should be sent to the FDA central document room at the following address:
 
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Prescription Drug Promotion
5901-B Ammendale Road
Beltsville, MD 20705-1266
 
To help avoid misdirection of your promotional materials, OPDP suggests applying a "OPDP" sticker [example sticker (PDF) ] other prominent directional notation to the exterior of packages submitted to OPDP. If it is not possible to add this notation to the exterior of the package, OPDP recommends adding a prominent directional notation (e.g., sticker, rubber stamp, etc.) to the cover letter itself. This notation should also be used on packages containing a OPDP submission and additional desk copies of the same material intended for another division within FDA.
 
Note: For any time sensitive materials other than proposed DTC TV advertisements, please confirm receipt of the submission by OPDP with a phone call to the relevant OPDP reviewer or the OPDP project manager at 301-796-1200. To confirm receipt of DTC TV advertisements submitted for advisory review, contact the OPDP project manager at 301-796-1200 or by email at CDER-OPDP-RPM@fda.hhs.gov.
 
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