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Category: Regulatory/FDA
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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03/07/2022
Fallout from Aduhelm Decision Could Undermine FDA Accelerated Approval Process
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02/28/2022
OPDP Warning Letter Cites CEO’s COVID Claims in Video for IND
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02/15/2022
Califf Is Confirmed as FDA Commissioner
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02/07/2022
Califf Confirmation in Jeopardy?
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