SAM02: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA

Description

Advertisements and promotional labeling of prescription drugs in the USA must comply with statutory and regulatory requirements. Advertising and promotion are also subject to guidance from the Food and Drug Administration (FDA) and from industry and professional codes of practice. By identifying the requirements and summarizing the extensive guidance that applies, this course and its companions will help you to advertise and promote your products without incurring legal or regulatory sanctions.

In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.

In companion courses, we set out the legal framework for regulation, and we deal with considerations that are particular to consumer-directed advertising and online promotion and to interactions with healthcare professionals.