Description
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.
Reference text in its original language
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.
Sources and references
Dates and sources are retained to help you verify the information. Translations are provided to facilitate reading; the official source governs conditions and requirements.
Source reference : https://calendar.carleton.ca/grad/courses/HLTH/