Regulatory Agenda Eyes DTC Ads and Med Guides

HHS has published its semiannual regulatory agenda that outlines numerous FDA rulemaking activities under development, such as a final rule entitled “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format” and proposed rules entitled “Medication Guide; Patient Medication Information” and “Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies.” Additionally, HHS says long-term actions under development at FDA include “Certain Requirements Regarding Prescription Drug Marketing (203 Amendment)” and “Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems for Human Drug and Biological Products.” To view the regulatory agenda, click here.