How Drugs Receive FDA Approval
The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is the watchdog agency that’s responsible for testing new medications before they are approved. Drug manufacturers seek approval from the FDA after they have conducted numerous clinical trials and submitted all of their data to the FDA for review. Drugs are approved only if the FDA believes the data supports the efficacy for the targeted indication and that the drugs’ risks are reasonable and manageable.