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Category: Regulatory/FDA

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

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Promotion of IND for Brain Cancer Treatment Prompts OPDP Enforcement Letter

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FDA Establishes Office of Oncologic Diseases to Streamline Drug Review Process

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Dr. Stephen Hahn Nominated for FDA Commissioner Position

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Gottlieb: Lack of Permanent FDA Commissioner Has an Impact

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

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

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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

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