Policy & Medicine
Legal, Regulatory, and Compliance Issues
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FDA
OPDP Sends Third Untitled Letter of the Year to Eton Pharmaceuticals
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FDA Reconsidering the Need for Mandatory Opioid Prescriber Education
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Woodcock Calls for HHS OIG Investigation Into Aduhelm Approval
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FDA Finalizes Guidance on Field Alert Report Submissions
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Amgen Receives Untitled Letter for Banner Ad Promoting Neulasta
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FDA Releases Draft Guidance on Sponsor Safety Reporting Requirements
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OPDP To Study Promotion of Prescription Drugs at HCP Conferences
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FDA Approves New Alzheimer’s Drug
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HHS and FDA Withdraw UDI Termination Notice
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FDA Issues Notice of Noncompliance for Failure to Submit Clinical Trial Results Data
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