Clinical Development

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All SubjectsClinical Development

Stakeholders interactions – Patients Affairs Staff

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEarly Access SupportPatient EngagementPatient AdviceFDA Regulatory AdvicePatient Affairs StaffPatient Support

At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

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Feasibility-Patient engagement in trial endpoint selection 

Published by IRDiRC

Research and Drug DevelopmentClinical DevelopmentEndpointPatient EngagementClinical TrialOutcome MeasureTrail Endpoint Selection

Guidance on the pivotal clinical trials outcomes measures .The important of the patient’s feedback. Academics can then assess whether there is an outcome measure available that can measure this – if not, outcome measure(s) may need to be developed.

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