Drug development and approval  sometimes seem like a mysterious process to a patient, caregiver or treating physician. Though complex and time consuming, the Food and Drug Administration (FDA) process to approve a new drug before it comes to market ensures that all marketed medicines meet important standards for patient safety and drug effectiveness.

Below is a brief description of the process and useful links for further information.

FDA is the federal agency responsible for the safety and effectiveness of drugs that are sold either by prescription of over-the-counter in the United States and it does so through its Center for Drug Evaluation and Research (CDER).

A drug company presents a new drug for approval to the FDA through a New Drug Application (NDA) submission. The submission includes laboratory evidence demonstrating safety and effectiveness in animal studies conducted by the drug company as well as human clinical trials.  The company submits a NDA to the FDA when it believes it has accumulated enough evidence to show that the drug is safe and effective (produces the intended outcome). These human clinical trials (sometimes called clinical studies) take place in steps or phases, with growing numbers of participants as the trial progresses from Phase I through Phase IV.  This process may take several months or years to complete.

Many are aware that FDA must issue an investigational new drug (IND) for an experimental drug that is tested in clinical trials. INDs are necessary because federal law requires that only marketed drugs may be transported or distributed across state lines. So, in order for pharmaceutical companies to ship unapproved drugs for marketing to clinical sites for testing, they must obtain an exemption from the FDA to ship the experimental medicines; hence, the IND.

Once received, the FDA reviews the NDA and all data and if approved, determines how the drug will be labeled, inspects the manufacturing facility and then approves the drug.

Though time consuming, this process offers to the public a way by which we can trust that our health and safety is respected. Thanks to the FDA, we can be confident that the medicines we take are designed to improve our health, are safe and are effective.

For more information on the drug development and approval process, see https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm  and https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143531.htm