Pharmaceuticals: Advertising and Promotional Labeling in the US
This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining some of the key FDA regulations and guidance documents to consider in producing compliant prescription drug and biologic promotional materials. Practical aspects for the review of promotional materials will be provided, along with key evidentiary standards required to substantiate claims. Examples of materials FDA found to be in violation of its advertising and promotional regulations are also included to help regulatory professionals understand FDA’s interpretation of the regulations. Finally, more recent topics in prescription drug promotion, such as the use of social media platforms and promotion of biosimilars, will be discussed.
At a Glance
- Target Audience: Regulatory advertising and promotion professionals with one to three years’ experience who are responsible for the review and approval of prescription product advertising and promotional materials.
- Learning Level: Basic
- Total Length of Course: 3 Hours
- RAC Points: 3
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:- Describe the statutory and regulatory authority over advertising and promotional materials
- Understand core elements of truthful and non-misleading advertising and promotion as described in key regulations and guidance documents and how these have been applied in enforcement actions
- Define what an advertisement or promotional labeling communication should include and exclude
- Identify evidentiary requirements to substantiate different promotional claims, how to determine consistency with FDA-approved labeling, and provide examples of relevant FDA enforcement actions
- Explain current FDA thinking regarding existing prescription drug advertising and promotion regulations as communicated in FDA guidance documents
Lesson Titles
- Lesson 1: Legal and Regulatory Background for Prescription Drug and Biologic Promotion
- Lesson 2: Framework for Review of Prescription Drug and Biologic Promotion
- Lesson 3: Claim Substantiation
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