How to Submit using eCTD and Paper Submissions
FDA Form 2253 submissions and requests for advisory comment submissions can be submitted to OPDP using eCTD or by sending paper copies. For information on how to submit please see guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs (PDF) for recommendations on how to submit in electronic (eCTD) and non-electronic format (paper).
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.
How to Submit Electronic Non-eCTD FDA Form 2253 Submissions
OPDP also accepts FDA Form 2253 submissions in electronic, non-eCTD, form (e.g., CDs) using acceptable file formats (PDF). Form FDA 2253 submissions do not require inclusion of a paper hard copy of the entire submission, except that a signed paper hard copy of the form must be included to allow for processing. Please see the recommendations below on how to organize your electronic (non-eCTD) submission.
Note: We are not accepting non-eCTD submissions through ESG (gateway).
Organizing the Main Folder
All documents should be placed in a main folder using the NDA, IND, or BLA number (e.g., N123456, I123456, or B123456, respectively) as the folder name.
Inside the main folder, you should include two folders, to organize the files supporting the submission. The promotional material(s) and supporting reference(s) should be placed in separate folders and labeled as such (for example, “promo” and “refs”). Please note that Form FDA 2253 submissions are not required to include references.
Forms FDA 2253
When submitting Form FDA 2253 (PDF), you should provide it as a PDF file inside the main folder and label as such (for example, “2253.pdf”).
In addition, a signed paper hard copy of Form FDA 2253 should accompany the electronic submission.
Current Labeling Text
You should provide a copy of the currently used labeling text as a PDF file in the main folder and label as such (for example, “current.pdf”).
Table of Contents
Inside the main folder, you should provide a table of contents for the submission and label as such (for example, “toc.pdf”).
You should supply a hypertext link to the corresponding file. For an example, see Table 1.
Table 1: Example Table of Contents for a Submission
|Form FDA 2253||Main/ “2253.pdf”|
|Current labeling||Main/ “current.pdf”|
|List promotional material starting here|
|List references starting here|
You should provide each promotional piece as an individual PDF file (or other acceptable file format (PDF)). You should place all promotional material PDF files in the folder dedicated to promotional materials. Please see the section entitled Presentation Issues in the guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs (PDF), regarding guidelines on how to submit electronic images of promotional materials.
If you choose to provide references with your 2253 submission, you should provide each reference as an individual PDF file and highlight the sections of the full reference that you refer to in the promotional material. You should place these files in the folder named refs. Whenever possible, you should generate the PDF files from electronic source documents and not from scanned material.
Please see the section entitled Annotated References in the guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs (PDF), regarding guidelines on how to annotated references.
Resources and Important Information
Please be sure to use the most current version of Form FDA-2253 and carefully read the submission instructions:
All questions concerning FDA Form-2253 submissions and requests for advisory comments may be directed to the OPDP project manager at 301-796-1200 or by email at CDER-OPDP-RPM@fda.hhs.gov. For any time-sensitive materials, please confirm receipt of the submission by OPDP.
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. All correspondences should be addressed to the attention of the OPDP Project Manager. Additionally, all correspondences which include materials on CD should include a statement indicating whether or not the contents of the CD match the contents of the physical submission. When submitting healthcare economic information directed to payors, formulary committees or similar entities under section 502(a) of the Federal Food, Drug, and Cosmetic Act, please indicate the material type to be “Formulary Economic” or “Formulary Kit,” as appropriate.