Business · 06/08/2020
FDA Announces Final Guidance for Limited Population Pathway for Antibacterial and Antifungal Drugs
The Food and Drug Administration (FDA) has released a final guidance document outlining the implementation of the limited population pathway provision of the 21st Century Cures Act, which allows for expedited review of antibacterial and antifungal drugs for rare populations.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →