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Category: Regulatory/FDA
10/28/2022
FDA Accelerated Approval Program Is Under Spotlight Again with Makena
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06/27/2022
OPDP: Risk, Efficacy Claims for Cholesterol Drug in Doctor Promotion Are False/Misleading
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06/20/2022
HHS Formally Withdraws SUNSET Final Rule
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06/13/2022
OPDP Reorg, Outreach Efforts Designed to Improve Relationship with Industry
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05/31/2022
OPDP to Study Risk/Benefit Tradeoff Decisions Made by Consumers, Physicians
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04/18/2022
Presentation of Risks in DTC Video, HCP Webpage Yields Enforcement Letter for Bausch Health
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04/12/2022
CMS Sticks to Plan: No Aduhelm Coverage Unless in Clinical Trial
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03/28/2022
OPDP To Study DTC Website Promotion of Accelerated Approval Drugs
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03/14/2022
Myers: Data Will Drive Califf’s Decisions at FDA
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