OPDP Electronic Submissions Update Annotations Multiple sections of the "Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs" Guidance for Industry (Electronic Submissions Guidance) describe the content of specific submission types and contain directions to include annotated promotional materials. But how should Submitters structure and format annotations when submitting annotated promotional materials? The Electronic Submissions Guidance includes instructions that describe what to include in a submission and in certain sections, submitters are directed to include the following items: - An annotated copy of the proposed promotional material(s) that clearly identifies the source of support for each claim (e.g., specific page and lines of the PI or specific page and column/paragraph from other references)
- The most current FDA-approved PI and, if applicable, the FDA-approved patient labeling or Medication Guide with annotations cross-referenced to the proposed promotional material
- If applicable, annotated references to support product claims not contained in the PI, cross-referenced to the promotional material
Section VI provides additional details regarding annotated product labeling. Specifically, Section VI.G states the following: For draft promotional materials submitted (1) voluntarily for advisory comment, or (2) under 21 CFR 314.550 or 601.45, include the annotated product labeling in section 1.15.2.1.3. Firms should highlight and annotate, with a cross-reference to the promotional materials, the sections of the product labeling that are referred to in the promotional materials. When product labeling is used to support a claim or presentation in proposed promotional materials, hypertext links should be provided to the specific page that contains the supporting information. For promotional materials submitted in fulfillment of the postmarketing reporting requirements, firms may choose to provide the annotated product labeling with hypertext links. Section VI.H provides details on annotated copies of reference documents: If references are provided, submit each reference as an individual PDF file and place it in section 1.15.2.1.4. Firms should highlight and annotate, with a cross-reference to the promotional materials, the sections of the full reference that are referred to in the promotional materials. When a reference is used to support a claim or presentation in proposed promotional materials, firms should provide, in the annotated promotional material, hypertext links to the specific page of the reference that contains the supporting information. For promotional materials submitted in fulfillment of the postmarketing reporting requirements, firms may choose to provide references with hypertext links. References improve the efficiency of review. To help illustrate the recommended structure and format of the annotations described in the guidance, OPDP has posted a mock advertisement submission. The mock advertisement submission includes a clean copy of a fictitious promotional material, an annotated copy of the promotional material, and an annotated copy of the PPI. The annotated PPI demonstrates the requested cross-reference annotations described in the guidance. Different examples of methods for annotating have been included in the mock ad to show various ways a submission could be annotated. However, we recommend using a consistent method throughout your submission for all references included in the submission. It's important to note that while hypertext links are requested in the guidance, they are not required. Nonetheless, including hypertext links in the annotations is encouraged and improves the efficiency of the review. Additionally, the mock advertisement includes an example of a CFL three-factor analysis (see earlier/later piece on the CFL guidance). The CFL-analyses included in the mock annotated ad are examples of how optional CFL-analyses could be included to help facilitate OPDP's review of information not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. |
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