Category: Regulatory/FDA

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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

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FDA After Gottlieb: Will Sharpless Stay the Course?

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

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OPDP Issues Enforcement Letter for Investigational Drug Promotion

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FDA Applies Increased Scrutiny to Nutritional Supplements Claiming Pain Relief