Category: Regulatory/FDA

CHC_general1

FDA Amps Up Foreign Inspections Under Pressure to Bend on Opposition to Drug Importation

CHC_DTCadvertisement2

OPDP DTC Research Studies Await Peer Review, Are Poised for Publication

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OPDP Warning Letter: Omission of Risk Info in DTC Print Ad/Display Banners Misbrands ED Drug

doctor story

OPDP to Study How Source, Graphics and Time Affect Physician Perceptions of Info

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Latest OPDP Enforcement Letters: Don’t Omit or Distract from Risk Information

News Aikin

OPDP’s Aikin Highlights Role of Social Science Research in FDA Promotional Policymaking

Myers News

FDA’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

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OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

Myers News

FDA After Gottlieb: Will Sharpless Stay the Course?