Definition · Plain-language
Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) is a federal agency within the United States Department of Health and Human Services, responsible for protecting and promoting public health.
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Organizational Structure and Key Centers
The FDA’s regulatory work is divided among several specialized centers, each overseeing a specific category of products. The Center for Drug Evaluation and Research (CDER) regulates small-molecule prescription and over-the-counter drugs. The Center for Biologics Evaluation and Research (CBER) oversees vaccines, blood products, and cell and gene therapies. The Center for Devices and Radiological Health (CDRH) regulates medical devices. Other centers manage food safety, cosmetics, veterinary medicine, and tobacco products. This compartmentalization ensures that reviews are conducted by scientists with domain-specific expertise.
Role in Research and Clinical Trials
The FDA regulates the research and development pipeline for new medicines and medical devices. Before a new drug can be tested in human volunteers, the sponsor must submit an Investigational New Drug (IND) application detailing preclinical testing. The FDA reviews the IND to ensure the proposed trials do not expose subjects to unreasonable risk. Throughout clinical trials, the FDA enforces Good Clinical Practice (GCP) to protect participants’ rights and ensure data integrity. Regulators may inspect clinical trial sites and institutional review boards (IRBs) to verify compliance.
Approval Pathways and Enforcement
To bring a product to market, sponsors must submit applications showing safety and efficacy: a New Drug Application (NDA) for small-molecule drugs, a Biologics License Application (BLA) for biological products, or a Premarket Approval (PMA) or 510(k) notification for medical devices. The FDA evaluates the scientific evidence, labels, and manufacturing facilities (verifying Good Manufacturing Practice, or GMP). Post-marketing, the FDA monitors adverse events, can mandate safety warning updates, and holds enforcement powers including warning letters, product recalls, and seizure of non-compliant goods.
Key facts
At a glance
- Definition: the US federal agency regulating food safety, human/veterinary drugs, medical devices, and biologics.
- Department: part of the US Department of Health and Human Services (HHS).
- CDER: Center for Drug Evaluation and Research (regulates chemical drugs).
- CBER: Center for Biologics Evaluation and Research (regulates vaccines and biologics).
- CDRH: Center for Devices and Radiological Health (regulates medical devices).
- Oversight: regulates preclinical research (IND), clinical trials (GCP), and manufacturing (GMP).
Common misconceptions
What people often get wrong
Often heard: The FDA conducts its own laboratory and clinical trials to test new drugs.
Actually: The FDA does not run clinical trials. The pharmaceutical company or sponsor must design, run, and pay for all trials. The FDA’s role is that of an evaluator: they review the data, methodology, and results submitted by the sponsor to judge whether the drug is safe and effective.
Often heard: FDA clearance and FDA approval are exactly the same thing.
Actually: They are distinct legal standards. The FDA 'approves' new drugs (NDAs/BLAs) and high-risk medical devices (PMAs) based on independent scientific evidence of safety and effectiveness. The FDA 'clears' moderate-risk medical devices (510(k)) based on substantial equivalence to an existing legally marketed device.
Common questions
FAQ
What does the FDA do in clinical trials?+
The FDA reviews the research plan (protocol) before trials begin via the IND application, monitors trial safety reports, and inspects research sites to verify that human subjects are protected and that the trial data is collected honestly and accurately.
What is the difference between CDER and CBER?+
CDER (Center for Drug Evaluation and Research) reviews chemically synthesized drugs like aspirin, antibiotics, and heart medicines. CBER (Center for Biologics Evaluation and Research) reviews biological products made from living sources, such as vaccines, blood products, and gene therapies.
Going deeper
