What is the FDA Approval Process for Cancer Drugs?
The FDA approval process for cancer drugs involves several stages:
Preclinical Testing: Laboratory and animal studies to gather initial efficacy and safety data. Investigational New Drug (IND) Application: Submission to the FDA for permission to start human clinical trials. Clinical Trials: Multi-phase human trials to test safety, efficacy, dosing, and side effects. New Drug Application (NDA) or Biologics License Application (BLA): Comprehensive submission of all data for FDA review. FDA Review: Detailed evaluation of the NDA/BLA, including advisory committee meetings, if necessary. Post-Market Surveillance: Ongoing monitoring of the drug’s performance in the real world.
