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payor communication

Regulatory/FDA

FDA Final Guidance Documents on Communication Issues Improve Clarity

FDA Final Guidance Documents on Communication Issues Improve Clarity

June 14, 2018 – Although they may not be perfect, the two final guidance documents issued this week by the FDA do provide more information and examples to help pharma companies navigate how they communicate with payors and how they ensure that their on-label communications are compliant. In a June 12 statement, FDA Commissioner Scott […]

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Regulatory/FDA

FDA Issues Draft Guidance on Payor Communications

FDA Issues Draft Guidance on Payor Communications

Jan. 27, 2017 – The FDA recently announced the availability of draft guidance for industry covering manufacturer communications with payors and formulary committees, which “provides answers to common questions regarding  the communication of health care economic information (HCEI) about approved prescription drugs” by manufacturers. The document also addresses manufacturer communications regarding investigational products. “FDA is […]

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