Business · 30/09/2021
FDA Releases Draft Guidance on Benefit-Risk Assessment for New Drug and Biological Products
The FDA has announced the availability of a draft guidance document outlining the agency's approach to evaluating the benefits and risks of new drugs and biological products, in accordance with the Prescription Drug User Fee Act of 2017 and the 21st Century Cures Act.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →