FDA (Food and Drug Administration)

The U.S. Food and Drug Administration (FDA) is the federal agency, housed within the Department of Health and Human Services (HHS), responsible for protecting public health by regulating the safety and effectiveness of human and veterinary drugs, biological products, medical devices, and the U.S. food supply, among other product categories. For research administrators, investigators, and sponsors, FDA is the regulatory authority that determines whether — and under what conditions — a human clinical investigation of a drug, biologic, or medical device may proceed in the United States, and it is the agency that inspects trial sites, sponsors, and manufacturing facilities for compliance with its regulations.

What the FDA regulates in a research context

FDA’s authority over research-relevant activity centers on two related but distinct pathways, depending on the product type under investigation:

• Investigational New Drug (IND) applications (21 CFR Part 312) — required before a drug or biological product that has not been approved for a given use may be administered to human subjects, or shipped across state lines for that purpose. The IND is submitted to and reviewed by FDA before a clinical investigation can begin.
• Investigational Device Exemption (IDE) applications (21 CFR Part 812) — the parallel mechanism for a “significant risk” medical device being studied in human subjects. Devices classified as “nonsignificant risk” follow abbreviated IDE requirements rather than full FDA approval.

Which pathway applies, and which FDA center reviews it, depends on the product being studied — drugs and most biologics go through IND review; devices go through IDE review; and FDA’s own intercenter agreements resolve jurisdiction for combination products that don’t fall cleanly into one category.

FDA’s organizational structure: the centers relevant to research

FDA is organized into center-level components alongside its headquarters offices. Three centers are the ones a clinical or translational research administrator will encounter most directly:

• CDER — Center for Drug Evaluation and Research. Reviews IND applications and New Drug Applications (NDAs) for prescription and over-the-counter drugs, including generic drugs.
• CBER — Center for Biologics Evaluation and Research. Regulates biological products — vaccines, blood and blood products, cellular and gene therapies, and most allergenic and tissue products — under the Public Health Service Act (biologics reach the market via a Biologics License Application, or BLA, rather than an NDA).
• CDRH — Center for Devices and Radiological Health. Reviews IDE applications and premarket submissions (510(k), De Novo, PMA) for medical devices, and regulates radiation-emitting products.

FDA also includes centers with a narrower research-administration footprint — the Center for Veterinary Medicine (CVM), the Center for Tobacco Products (CTP), and the National Center for Toxicological Research (NCTR) — plus, following an October 2024 agency-wide reorganization, a unified Human Foods Program that absorbed most of the former Center for Food Safety and Applied Nutrition’s (CFSAN) functions. That same reorganization renamed the Office of Regulatory Affairs (ORA), FDA’s field-inspection arm, to the Office of Inspections and Investigations (OII). OII (through its BIMO — Bioresearch Monitoring — inspections) is the unit that physically inspects clinical trial sites, sponsors, IRBs, and manufacturing facilities on FDA’s behalf, regardless of which center holds jurisdiction over the product under study.

How FDA oversight touches a clinical trial in practice

A research administrator working on an FDA-regulated trial encounters the agency at several distinct points:

• Before enrollment — an IND or IDE must be active (or the study must qualify for an exemption, such as most Phase 1 CGMP exemptions or nonsignificant-risk device status) before human subjects can be exposed to the investigational product.
• Documenting investigator qualifications — for drug/biologic trials under an IND, the sponsor collects a completed FDA Form 1572 (Statement of Investigator) from each participating investigator, and 21 CFR 312.53(a) requires sponsors to select investigators “qualified by training and experience” — a standard commonly satisfied, though not government-mandated as a specific credential, through documented Good Clinical Practice (GCP) training.
• During the trial — sponsors must meet IND safety-reporting obligations (21 CFR 312.32) for unexpected serious adverse events, and the trial must be conducted under Good Clinical Practice standards aligned with ICH E6.
• Inspection — OII investigators conduct BIMO inspections of trial sites, sponsors, and IRBs, and separately inspect manufacturing facilities for Good Manufacturing Practice (GMP) and nonclinical laboratories for Good Laboratory Practice (GLP) compliance. An inspection that turns up conditions an investigator judges may violate the FD&C Act results in an FDA Form 483 listing the observations; uncorrected or inadequately addressed 483 findings can escalate to a formal Warning Letter.
• Electronic records — where a trial’s electronic data capture, laboratory, or manufacturing systems generate records intended to support an FDA submission, those systems generally need to meet 21 CFR Part 11‘s electronic records/electronic signatures requirements.

FDA and other bodies research administrators may confuse it with

• FDA vs. OHRP. Both oversee aspects of human-subjects protection, but their jurisdiction differs: FDA’s own human-subjects regulations (21 CFR Parts 50 and 56, covering informed consent and IRB review) apply to research regulated by FDA — i.e., studies of an investigational drug, biologic, or device — regardless of funding source. OHRP‘s Common Rule authority (45 CFR 46) instead reaches HHS-conducted or HHS-supported research, and any other research an institution has voluntarily brought under its Federalwide Assurance. A single multi-site trial can be subject to both frameworks simultaneously.
• FDA vs. ICH. The International Council for Harmonisation (ICH) is not a regulator — it is the body that develops harmonized technical guidelines, including the E6 Good Clinical Practice guideline, that FDA (along with the EMA and other national regulators) then adopts into its own guidance. FDA issued its own final guidance implementing ICH E6(R3) in September 2025.
• FDA vs. IRB. An Institutional Review Board reviews and approves individual study protocols and consent documents at the local or central level; FDA does not review or approve individual protocols directly (with limited exceptions) but sets the regulatory framework IRBs and sponsors must operate within, and inspects IRB records and conduct.

Origins and mandate, briefly

FDA traces its enforcement authority to the 1906 Pure Food and Drugs Act, initially enforced by the U.S. Department of Agriculture’s Bureau of Chemistry, which was renamed the Food and Drug Administration in 1930. The Federal Food, Drug, and Cosmetic Act of 1938 — passed after the Elixir Sulfanilamide poisoning deaths — replaced the 1906 statute and established the modern requirement that new drugs demonstrate safety before marketing, the foundation of the premarket review authority FDA still exercises today. FDA is headquartered on the White Oak campus in Silver Spring, Maryland.

Frequently asked questions

What is the difference between FDA and the FDA’s centers like CDER or CBER?

FDA is the parent agency; CDER, CBER, and CDRH (along with several other centers) are its component organizations, each with jurisdiction over a different category of regulated product. A sponsor or investigator interacts with the specific center that has jurisdiction over the product under study, not with “FDA” as an undifferentiated whole.

Does every clinical trial need FDA authorization?

No. FDA authorization (an active IND or IDE, or a qualifying exemption) is required specifically for trials studying a drug, biologic, or device that is not yet approved for the use being studied, or that is being shipped in interstate commerce for investigational use. Purely observational studies, or trials using only approved products within their approved labeling and not otherwise subject to IND/IDE requirements, may fall outside FDA’s premarket-authorization pathways, though other regulations (such as the Common Rule) can still apply.

What is the FDA’s role after a drug or device is approved?

FDA’s postmarketing authority continues after approval — including adverse-event reporting requirements, postmarketing (Phase 4) study commitments, facility inspections, and enforcement action if new safety information or noncompliance emerges.

Is “FDA-regulated research” the same as “FDA-approved research”?

No. “FDA-regulated” describes research that falls within FDA’s statutory jurisdiction (an investigational drug, biologic, or device) and is therefore subject to FDA’s rules for conducting it — it does not mean FDA has approved or endorsed a specific protocol.

Related CASRAI resources: Clinical Research Administration, Clinical Trial Phases: FDA Definitions, Milestones, and Trial Administration, What Is a Clinical Trial? The NIH Definition Explained, Investigational Medicinal Product (IMP), and Contract Research Organization (CRO).