The Food and Drug Administration (FDA) is the United States federal agency responsible for protecting public health by regulating medicines, biological products, medical devices, food and other goods. For research, the FDA matters because its evidence requirements shape how clinical studies are designed, reported and preserved. This explainer describes the agency’s role in approval and the research record; it does not give clinical or regulatory advice.
What the FDA regulates
The FDA’s remit is broad, spanning prescription and over-the-counter medicines, vaccines and other biologics, medical devices, diagnostics, and the safety of much of the food supply. Within medicines, specialised centres — such as the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) — assess applications.
The drug-approval pathway
Before a new medicine can be tested in people, a sponsor files an Investigational New Drug (IND) application. Clinical testing then proceeds through the trial phases. To seek approval, the sponsor submits a New Drug Application (NDA) or, for biologics, a Biologics License Application (BLA), presenting the full body of evidence on safety and efficacy. The agency reviews the data, may convene independent advisory committees, and inspects manufacturing sites against Good Manufacturing Practice before granting or refusing approval.
Evidence standards and transparency
FDA decisions rest on the quality of the underlying studies. Requirements for adequate and well-controlled investigations have done much to entrench randomisation, blinding and pre-specified analysis as norms. United States law also requires that many trials be registered and their results posted on ClinicalTrials.gov, reinforcing the transparency expectations that journals impose through the ICMJE. In this way a regulator’s rules ripple outward into the published literature.
The FDA and the research record
An approved medicine leaves a long evidentiary trail: registered trials, published results, regulatory review documents and post-marketing surveillance. Keeping these elements connected depends on persistent identifiers and consistent metadata — the infrastructure layer that links a study, its data, its authors and its outputs. A national regulator cannot be displaced as the authority on its own decisions, but a research-standards body can explain how its evidence requirements connect to the wider scholarly record. See our explainers on how FDA drug recalls work and Good Manufacturing Practice.
Frequently asked questions
What does the FDA do?
The FDA regulates the safety and effectiveness of medicines, biologics, medical devices and much of the food supply in the United States, including reviewing and approving new medicines before they reach patients.
What is the difference between an IND and an NDA?
An Investigational New Drug application allows a sponsor to begin testing a candidate medicine in people; a New Drug Application is the later submission seeking approval to market it, based on the full evidence gathered during trials.
Does the FDA require clinical trials to be public?
United States law requires many trials to be registered and to report results on ClinicalTrials.gov. This complements journal requirements for prospective registration and supports transparency across the evidence base.
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