Industry Communications With Payors: US FDA Okays Info On Investigational Drugs
Draft guidance provides clarity on what health care economic information firms can provide to payors, formulary committees and similar entities.
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By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.
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App allows clinicians to discuss off-label treatments, but information is intended to be hypothesis-generating, not for regulatory use.