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It’s Now Time for Your OPDP Submissions to be FDA Compliant | Are You Ready?

The Prescribing Information, Labeling, and any other materials used for the promotion of Drug Products for their approved indication, or intended purpose of use, are referred to by the US Food and Drug Administration (FDA) as “Promotional Labeling and Advertising Materials for Human Prescription Drugs.” It is imperative that each Marketing Authorisation Holder (MAH) submits these Promotional Labeling and Advertising Materials to the FDA for review and approval for each of their drug products. In the next lines, Prabu Selvaraj at Navitas Life Sciences discusses the two types of labelling recognised by the FDA.


‘It’s Now Time for Your OPDP Submissions to be FDA Compliant | Are You Ready?’

The FDA generally recognises two types of labeling for a Product:

  1.  Labeling required for Product Approval – Prescribing Information, Package Insert/ Patient Information, and Structured Product Labeling, etc.
  2. Promotional labeling – Advertising materials, television advertisements, brochures, booklets, detailing pieces, websites, print advertisements, sound recordings, and radio advertisements, etc.

Effective from June 24, 2021, the FDA have made it mandatory that the following Office of Prescription Drug Promotion (OPDP) submission types will only be accepted in eCTD format and may only be submitted through the Electronic Submissions Gateway (ESG) as per Section 745A(a) of the Food, Drug, and Cosmetics Act.

Best Practises | 2253 Submissions
Form 2253

  • The current version of the fillable Form 2253 must be used
  •  Include the appropriate NDA, ANDA, or BLA number
  •  For OPDP, ensure that submissions that
    require correspondences are addressed
    for the attention of the OPDP Project

On Form 2253, Section 13 titled “ForCBER Products Only”:

  • For OPDP Submissions: Do NOT check the “Draft” or “Final” boxes
  • For Advertising and Promotional Labeling Branch (APLB) Submissions: Check the “Final” box only for Final post-marketing submissions

On Form 2253, Section 2 titled “Application Information”:

  • For a Single Product: Submission should include product details of only one application number
  • For Multiple Products: Submission should include lead application details and attach separate sheet that identifies the other referenced products (e.g. application type and number, trade name, and established name).

For 2253 submissions to OPDP, if a drug has multiple approved indications that are covered by different reviewers in OPDPi,firms should submit (when possible) promotional materials that only promote one indication separately from promotional materials that promote only another indication. In such cases, firms may choose to communicate the indication being promoted in the promotional materials in the Comments section of Form FDA 2253.

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