What is the drug approval process for cancer treatments?
The drug approval process for cancer treatments typically involves several phases:
Preclinical Testing: Laboratory and animal studies to determine if the drug is safe for human testing. Investigational New Drug (IND) Application: Submission to the FDA to begin clinical trials in humans. Clinical Trials: Conducted in three phases to test the drug's safety, efficacy, and optimal dosing. Phase I tests safety, Phase II evaluates efficacy, and Phase III confirms effectiveness in larger populations. New Drug Application (NDA): Submission to the FDA for a comprehensive review. If the drug is deemed safe and effective, it receives approval for marketing.