Category: Regulatory/FDA

FDA News

02/17/2020

Will FDA’s Budget and Drug Approval Momentum Continue Past 2020?

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02/03/2020

Impact of Celebrity, Influencer Drug Product Endorsements to Be Studied by OPDP

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01/27/2020

OPDP To Explore Promotional Implications of Drug Names

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12/20/2019

Press Release Highlighting Omission of Risk Warning Letter Closes OPDP’s Enforcement Year

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12/01/2019

Promotion of IND for Brain Cancer Treatment Prompts OPDP Enforcement Letter

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11/08/2019

FDA Establishes Office of Oncologic Diseases to Streamline Drug Review Process

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11/01/2019

Dr. Stephen Hahn Nominated for FDA Commissioner Position

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10/14/2019

Gottlieb: Lack of Permanent FDA Commissioner Has an Impact

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10/07/2019

OPDP Cites Risk Presentation Issues in YouTube Video, Email in New Enforcement Letters