What is the US Food and Drug Administrations role in the discovery and development of new medicines?
A. The Food and Drug Administration (FDA) is responsible for deciding whether a newly developed prescription medicine is safe and effective for patients to use—this is commonly referred to as “FDA approval.” The FDA must give its approval before a pharmaceutical company can begin testing a new medicine; the agency then monitors the company’s rigorous clinical trials. FDA approval comes only after long and careful review of the scientific and clinical trial data submitted by the pharmaceutical company developing the medicine. The FDA has taken less time to consider a new medicine for approval in recent years. However, requirements of lengthier and larger clinical trials have increased the total time it takes to bring a new medicine to market. The FDA continues to monitor medicines once they are on the market.
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