Deze vertaling wordt voorbereid. Voorlopig tonen we de oorspronkelijke Engelse versie.
Bedrijven · 26-1-20221 min lezen
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
Lokale automatische vertaling · Oorspronkelijke brontaal
Samenvatting
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Patient Engagement in the Design and Conduct of Medical Device Clinical Studies." The Patient Engagement Advisory Committee (PEAC) recommended that FDA and industry develop a framework to clarify how patient advisors can engage in the clinical investigation process. This guidance focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical studies.
Oorspronkelijke brontaal: Federal Register — Food and Drug AdministrationOrigineel bericht openen →