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Regulatory/FDA

OPDP Issues Warning Letter for Omission of Risks, Material Facts

OPDP Issues Warning Letter for Omission of Risks, Material Facts

Sept. 8, 2017 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued only two enforcement letters this year, its Aug. 24 Warning Letter to Cipher Pharmaceuticals followed a clear pattern: pursuing alleged omission of risk and omission of material facts. The letter to Cipher (ConZip Warning Letter), which licenses its ConZip® opioid […]

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