FDA Fast Track
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days.
Beyond's analysis on FDA Fast Track
Recent news mentioning FDA Fast Track
- — FDA Fast Track Puts Erasca’s (ERAS) Pancreatic Bet Center Stage
- — T-MAXIMUM B7-H3-Targeted Allogeneic CAR-T Therapy MT027 Receives FDA Fast Track Designation, Accelerating Global Development for Intracranial Solid Tumors
- — Cellenkos Receives FDA Fast Track Designation for CK0803 in Amyotrophic Lateral Sclerosis (ALS)
- — Nuvation Bio Granted FDA Fast Track Designation for Safusidenib for Treatment of IDH1-Mutant Glioma
- — Consano Bio Receives FDA Fast Track Designation for C-1101 in Chronic, Painful Lumbosacral Radiculopathy (LSR) or Chronic Sciatica
- — Phanes Therapeutics Receives FDA Fast Track Designation for Spevatamig in Advanced and Metastatic Biliary Tract Carcinoma
- — Insilico Medicine Receives FDA Fast Track Designation for ISM6331, the AI-driven Pan-TEAD Inhibitor, in Advanced Mesothelioma