Beskrivelse
Regulatoriske myndigheter (Health Canada, US Food and Drug Administration, European Medicines Agency) vil bli sammenlignet. Harmoniseringsarbeid mellom nasjonale legemiddelmyndigheter, tidslinjer for en investigational New Drug Application inkludert merking, akselerert godkjenning, breakthrough-utnevnelse, orphan drugs og biologics licence application.
Referansetekst i originalspråket
Regulatory agencies (Health Canada, US Food and Drug Administration, European Medicines Agency) will be compared. Harmonization efforts of national drug approval agencies, timelines for an investigational New Drug Application including labeling, accelerated approval, breakthrough designation, orphan drugs, and biologics licence application.
Kilder og referanser
Datoer og kilder beholdes for å hjelpe deg å verifisere opplysningene. Oversettelsene tilbys for å lette lesing; den offisielle kilden er referansen for krav og betingelser.
Kildereferanse : https://calendar.carleton.ca/grad/courses/HLTH/