What is the Role of Regulatory Authorities in Drug Approval?
Regulatory authorities like the FDA and EMA are responsible for the review and approval of new cancer drugs. This process involves rigorous evaluation of clinical trial data to ensure that the drug is both safe and effective for patients. The approval process includes several phases, from preclinical studies to clinical trials, and ends with a thorough review of all submitted data. These authorities also monitor post-market safety to ensure long-term efficacy and safety of the drugs.
