A drug company hoping to sell a drug in the United States must provide the U.S. Food and Drug Administration with research-based evidence proving the drugs benefits are greater than the risks. The FDA conducts an unbiased evaluation of the research before approving the drug for sale, states the FDA.
Drug companies must first test the drug on animals in order to prove the drug is safe to test on humans. Once the drug is deemed safe for human testing, it must pass various human studies to prove the drug is safe and effective for treatment of a specific disease or condition, explains the FDA. The FDA's Center for Drug Evaluation and Research conducts a thorough analysis of the evidence and approves the drug for public use only if the drug passes all of the safety and effectiveness tests.