U.S. FDA Drug and Product Approvals Explained
Author: Disabled World (DW)
Updated/Revised Date: 2 Nov 2026
Table of Contents:
Synopsis - Definition - About This Section - FAQs - Publications - Subtopics
Synopsis
An overview of the U.S. FDA and how it approves drugs and products, covering new drug applications, generic and over-the-counter drugs, and what the agency regulates.
At a Glance
- 1 - Since 2009, the FDA has had authority to regulate tobacco products.
- 2 - A single generic competitor can cut a drug price by about 30 percent, and five competitors by nearly 85 percent.
- 3 - New drugs undergo extensive review through a New Drug Application and are available only by prescription by default.
- 4 - Generic drugs gain approval through an Abbreviated New Drug Application that shows they are therapeutically equivalent to the original.
Topic Definition
- U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration, known as the FDA or USFDA, is an agency of the Department of Health and Human Services responsible for protecting and promoting public health through the regulation and supervision of a wide range of products. Its oversight extends across food safety, tobacco products, dietary supplements, prescription and over-the-counter medications, medical devices, radiation-emitting devices, vaccines, biopharmaceuticals, blood transfusions, veterinary products, and cosmetics. The depth of regulation varies by product type and potential risk, so the agency controls nearly every facet of prescription drugs, from testing and manufacturing to labeling and advertising, while its focus on cosmetics centers mainly on labeling and safety. New drugs reach the market through a New Drug Application, generics through an Abbreviated New Drug Application, and over-the-counter products from a defined set of approved ingredients, all reflecting the FDA's central role in confirming that products are safe and effective when used as directed.
Overview
The United States Food and Drug Administration (FDA or USFDA) is an agency of the U.S. Department of Health and Human Services. It protects and promotes public health by regulating and supervising food safety, tobacco products, dietary supplements, prescription and over-the-counter medicines, vaccines, blood and other biological products, medical devices, products that give off radiation, veterinary products, and cosmetics.
The FDA's powers vary with the type of product and its risks. The agency regulates almost every part of prescription drugs, including testing, manufacturing, labeling, advertising, effectiveness, and safety. Its oversight of cosmetics and dietary supplements is lighter: these products do not need FDA approval before they are sold, and the agency acts mainly once they are on the market. The Modernization of Cosmetics Regulation Act of 2022 gave the FDA new powers over cosmetics, including facility registration, product listing, and mandatory recalls.
The FDA's food safety and nutrition work is led by its Human Foods Program, which brings all of the agency's food activities together in a single group under the Deputy Commissioner for Food [U.S. Food and Drug Administration, n.d.].
New Drugs
New drugs receive extensive review before approval, through a New Drug Application (NDA); new biological products, such as many vaccines and antibody medicines, go through a Biologics License Application. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status is a separate process, and the drug must first be approved through an NDA. An approved drug has been judged to be safe and effective when used as directed.
Generic Drugs
Generic drugs are equivalents of name-brand drugs whose patents and other market protections have ended. They are usually made by other companies and cost less. To approve a generic drug, the FDA requires an Abbreviated New Drug Application (ANDA) with scientific evidence that the generic is therapeutically equivalent to the original drug. Competition from generics lowers prices: a single generic competitor can lead to price reductions of about 30 percent, and five competing generics are associated with price drops of nearly 85 percent [U.S. Food and Drug Administration, 2021].
Over-the-Counter (OTC) Drugs
OTC drugs are medicines that can be bought without a prescription. Many are sold under OTC monographs, which set the acceptable ingredients, doses, and labeling for each type of product, and many OTC ingredients were once prescription drugs that are now considered safe enough to use without a doctor's supervision.
Quick Facts on the FDA
- Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA has had authority to regulate tobacco products.
- The Center for Drug Evaluation and Research (CDER) oversees most drugs, and the Center for Biologics Evaluation and Research (CBER) oversees vaccines, blood products, and other biologics.
- The Center for Devices and Radiological Health (CDRH) regulates medical devices and products that give off radiation, including the premarket review of devices and oversight of their manufacturing, performance, and safety.
- The Center for Veterinary Medicine (CVM) regulates food, food additives, and drugs given to animals, including food animals and pets.
- Generic drugs saved the U.S. health care system an estimated $2.2 trillion from 2009 to 2019, according to the IMS Health Institute, as cited by the FDA.
- Before the 1990s, only about 20 percent of drugs prescribed for children in the United States had been tested for safety or effectiveness in children.
- The FDA's headquarters is on the White Oak campus in Silver Spring, Maryland.
Frequently Asked Questions
How long does the FDA drug approval process take?
Approval timelines vary widely because a drug must move through preclinical work, several phases of clinical trials, and formal review, a path that commonly spans many years before a medicine reaches patients.
What are the phases of FDA clinical trials?
Clinical trials generally move through phases that first test safety in small groups, then measure effectiveness and side effects in larger groups, before confirming results in broad populations ahead of approval.
What is the difference between an NDA and an ANDA?
A New Drug Application is used to approve a brand new drug with full testing data, while an Abbreviated New Drug Application approves a generic by showing it is equivalent to an already approved drug.
Does FDA approval mean a drug is completely safe?
Approval means the benefits are judged to outweigh the risks when a drug is used as directed, but no drug is entirely free of risk, and the FDA continues to monitor safety after approval.
How does the FDA monitor drugs after they are approved?
The agency tracks safety through post market surveillance, adverse event reporting, and inspections, and it can require label changes, warnings, or withdrawals if new risks come to light.
Can you import drugs that are not approved by the FDA?
Importing unapproved drugs is generally restricted, and the FDA monitors imports closely, so consumers should be cautious of products that have not been reviewed for safety and quality.
Does the FDA approve dietary supplements before they are sold?
Dietary supplements are not approved by the FDA before sale in the way drugs are, since manufacturers are responsible for safety while the agency acts mainly after products reach the market.
What is an FDA boxed warning?
A boxed warning, sometimes called a black box warning, is the strongest safety warning the FDA requires on a drug label. It highlights serious or life-threatening risks that doctors and patients should weigh.
References
- U.S. Food and Drug Administration. (2021). Generic drug facts.
- U.S. Food and Drug Administration. (n.d.). Human Foods Program.
- U.S. Food and Drug Administration. (n.d.). What we do.
Curated and edited by Ian C. Langtree, Founder and Editor-in-Chief, Disabled World. This section is maintained by the Disabled World editorial team. Last updated: