FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

In November 2023, the U.S. Food and Drug Administration (FDA) published its final rule (Rule) to amend its regulations concerning radio and television direct-to-consumer (DTC) advertisements (ads) for human prescription drugs by firms, which includes manufacturers, packers, and distributors of prescription drugs and all of their representatives, including both individuals and corporate entities (Prescription Drug Firms)……
By: Foley & Lardner LLP