AMAG’s Vyleesi Review Offers Lessons On Impact Of Patient Input

US FDA accepted change in Phase III endpoint hierarchy for the hypoactive sexual desire disorder drug based on input from a patient-focused drug development meeting and scientific workshop; bremelanotide review documents advise on use of multiple anchor scales to help interpret meaningfulness of changes in clinical outcome assessment scores.

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Patient Input Helped Inform US FDA Views On Endpoints, Clinical Outcome Assessments

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