Category: Regulatory/FDA

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03/18/2019

New FDA Guidance on Clinical Trial Design—and an Admonition from Commissioner Gottlieb

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03/13/2019

Sharpless to Succeed Gottlieb at FDA on Acting Basis

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03/06/2019

Gottlieb Departure from FDA Surprises Industry

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02/28/2019

CDRH Issues Warning Letter for Device Cancer Diagnosis Claims in Brochures, on Website

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11/02/2018

OPDP Cites Lack of Risk Information in Second Warning Letter of 2018

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10/22/2018

Three New OPDP Research Studies to Cover Broad Array of Promotional Activities

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10/19/2018

Bad Ad Program Yields Two OPDP Enforcement Letters on Risk, Safety Information

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10/04/2018

CDER’s Woodcock Says First Amendment Concerns Dampen OPDP Enforcement

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08/30/2018

EstroGel Sell Sheet Efficacy Claim Cited in 4th OPDP Enforcement Letter of 2018