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May 16, 2024
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements...
February 13, 2024
On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation...
February 6, 2024
On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis...
January 24, 2024
In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and radio format (CCN Final Rule Guidance).
January 19, 2024
In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements,...
January 11, 2024
On December 26, 2023, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a Questions and Answers Guidance for industry titled “Direct-to-Consumer...
January 9, 2024
As 2023 came to a close, the U.S. Food and Drug Administration issued a new rule on direct-to-consumer prescription drug advertising along with business guidance to assist companies with compliance.
January 8, 2024
FDA issued a new Q&A Guidance, which provides helpful context and examples for compliance with its November Direct-to-Consumer Clear...
January 3, 2024
On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements:...
December 26, 2023
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule Questions and Answers