Pharmaceuticals: Advertising and Promotional Labeling in the US
This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional materials. Practical aspects for the review of promotional materials will be provided, along with key evidentiary standards required to substantiate claims. Emerging trends in promotion (i.e., use of social media) will also be discussed.
At a Glance
- Target Audience: Regulatory 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 material
- Define what an advertisement or labeling piece should include and exclude
- Cite resources to find guidance on regulatory submission
- Identify evidentiary requirements to substantiate different promotional claims and provide examples of FDA enforcement actions related to inadequate claim substantiation
- Explain how existing prescription drug advertising and promotion regulations can be applied to online promotion and social media and provide related examples of FDA enforcement actions
Lesson Titles
- Lesson 1: Regulatory Framework for Prescription Drug and Biologic Promotion
- Lesson 2: Framework for Review of Rx Drug and Biologic Promotion
- Lesson 3: Claim Substantiation
- Lesson 4: Emerging Trends in Prescription Drug Promotion
This course is also included in:
