New Accelerated Approval Guidance Underscores Need for Accountability

On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and Biologics Guidance for Industry” (the “Draft Guidance”)……
By: Sheppard Mullin Richter & Hampton LLP