On June 24, 2019, FDA issued a final guidance for industry entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format--Promotional Labeling and Advertising Materials for Human Prescription Drugs. This guidance finalizes the draft guidance issued in April 2015. This final guidance outlines the requirements and recommendations for various types of promotional material submissions for prescription drugs and biological products, including the specific formats needed for use in the electronic common technical document (eCTD) as well as non-eCTD and non-electronic formats. Effective June 24, 2021, firms are required to submit electronically all promotional submissions that fall within the scope of section 745A(a) as specified in this guidance. Questions related to the content and format of eCTD submissions to OPDP may be sent to OPDPeCTD@fda.hhs.gov..
The OPDP eCTD page contains all resources and reference materials produced by OPDP in support of the OPDP Electronic Submissions Guidance.
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 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 of promotional materials to CDER may be directed to OPDPeCTD@fda.hhs.gov
What’s New in the OPDP Electronic Submissions Final Guidance?
On August 12, 2019, OPDP recorded a webinar titled “What’s New in the OPDP Electronic Submissions Final Guidance?” The presentation provides an overview of the changes between the draft and final versions of the OPDP Electronic Submissions Guidance.
OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them
On October 25, 2019, OPDP presented a webinar titled “OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them.” The webinar provides an overview of the common errors OPDP observes in promotional submissions in eCTD format. The webinar also discusses the test submission process including steps for submitting test files to OPDP and the development of test cases to prevent the common errors discussed in the presentation. The webinar was recorded live and includes a Q&A session at the conclusion of the presentation.
Ad/Promo eCTD Submissions Roundtable
On November 19, 2019, OPDP moderated a roundtable discussion with presenters from Eli Lilly, Otsuka Pharmaceuticals, and Agios Pharmaceuticals. During the discussion, each panel member presented their company’s implementation strategy for the transition to eCTD Ad/Promo submissions. Each presenter discussed the timeline for transitioning to eCTD, their experiences during the transition process, challenges, and lessons learned. The presenters also shared several best practices which were developed through their eCTD implementation experience.
Promotional Submission How-To Videos
OPDP has prepared a series of how-to videos targeted at submitters who are preparing promotional material submissions in eCTD format. The videos in this section provide an overview of the content and eCTD structure requirements for the most common types of OPDP Submissions.
2253 How-To Video
The 2253 How-to video provides an overview of the required files and placement of those files within the eCTD table of contents. The video also provides an example of a properly structured 2253 submission in eCTD format.
Advisory How-To Video
The Advisory How-to video provides an overview of the content that should be included in a Voluntary Request for Comment submission. The video also details the placement of the content files within the eCTD table of contents as well as providing an example of a properly structured Advisory submission in eCTD format.
Accelerated Approval How-To Video
The Accelerated Approval How-to video provides an overview of the content requirements for the Presubmission of Promotional Materials for Accelerated Approval Products. The video discusses the Launch and Non-Launch periods associated with Accelerated Approval Submissions, file requirements, and provides an example of a properly structured Accelerated Approval Submission in eCTD format.
Promotional Submission Reference Documents
Instructions for Submitting via the CDER nextGen Portal
Submitters should follow these steps to submit advertising and promotional labeling submissions through the CDER nextGen Portal. The user guide for the CDER nextGen Portal can be found here.
- Log into the CDER nextGen Portal
- On the Welcome Screen, select the menu option for the “FDA Alternate Submission”
- On the FDA Alternate Submission Screen, select “Create New Submission”
- On the FDA Alternate Submission Information screen, select a Submission Type of “Marketing and Advertising” and enter the Product’s Application Number.
- Click the “Next” button
- On the “Attach Documents” screen, upload the documents to be submitted
- Use the “Form 2253” material type to upload the Form 2253
- Use the “Cover Letter” material type to upload a cover letter – only use when a Form is not required
- Use the “Label” material type to upload the Label
- Use the “Materials” material type to upload the promotional materials listed on the Form FDA 2253 or Cover Letter
- After uploading all materials, click the “Review” button to review the Submission
- Verify the submission is complete and accurate and submit the record.
Submitters may forward any questions related to the submission of promotional materials to OPDPeCTD@fda.hhs.gov
Response to Untitled/Warning Letter – Frequently Asked Questions
- Can a Response to an Untitled or Warning Letter (UL/WL) be submitted in eCTD?
- Yes – The cover letter should be placed under Heading 126.96.36.199 in the eCTD table of contents.
- Should a Response to UL/WL include a Form?
- No – The Response to UL/WL should only include the cover letter and should not include a Form.
- Can I submit a Test eCTD Submission of a Response to UL/WL?
- Yes – OPDP encourages Submitters to submit a test Response to UL/WL. OPDP suggests that Submitters should document the process for submitting a Response Letter and include these steps in their Response Plans.
- Does OPDP provide any resources to help prepare a mock submission of a Response to UL/WL?
- Yes – Submitters can find the OPDP Test Submission checklist for the Response to UL/WL Submission at this link. The checklist can be used to verify that the eCTD table of contents is structured correctly.
- If a Firm receives an Untitled or Warning Letter, who can they contact if they have any questions regarding a Response to UL/WL in eCTD format?
- Please send any questions to OPDPeCTD@fda.hhs.gov