Category: Regulatory/FDA

News Sharpless (1)

05/06/2019

FDA Leaders Highlight Issues, Opportunities of Real-world Data Post-marketing

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04/30/2019

OPDP Issues Enforcement Letter for Investigational Drug Promotion

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03/28/2019

FDA Applies Increased Scrutiny to Nutritional Supplements Claiming Pain Relief

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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