U.S. FDA Drug and Product Approvals Explained
Author: Disabled World (DW)
Updated/Revised Date: 4 Aug 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 - The FDA regulates more than one trillion dollars in consumer goods, about twenty-five percent of U.S. consumer spending.
- 2 - New drugs undergo extensive review through a New Drug Application and are available only by prescription by default.
- 3 - Generic drugs gain approval through an Abbreviated New Drug Application that shows they are therapeutically equivalent to the original.
- 4 - The agency lists roughly 800 approved ingredients that are combined to create more than 100,000 over-the-counter drug products.
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 United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), medical devices, electromagnetic radiation emitting devices (ERED), vaccines, biopharmaceuticals, blood transfusions, veterinary products, and cosmetics.
The FDA regulates more than $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements.
Much of the expenditures is for goods imported into the United States; the FDA is responsible for monitoring a third of all imports.
The programs for safety regulation vary widely by the type of product, its potential risks, and the regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety, yet FDA regulation of cosmetics is focused primarily on labeling and safety.
New Drugs:
Receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. 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 be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed."
Generic Drugs:
Are chemical equivalents of name-brand drugs whose patents have expired. Generally, they are less expensive than their name brand counterparts, are manufactured and marketed by other companies and, in the 1990s, accounted for about a third of all prescriptions written in the United States. For approval of a generic drug, the U.S. Food and Drug Administration (FDA) requires scientific evidence that the generic drug is interchangeable or therapeutically equivalent with the originally approved drug. This is called an "ANDA" (Abbreviated New Drug Application).
Over-the-counter (OTC) Drugs:
Are drugs and combinations that do not require a doctor's prescription. The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision.
Quick Facts on The U.S. FDA
- The FDA's federal budget request for fiscal year (FY) 2012 totaled $4.36 billion, while the proposed 2014 budget is $4.7 billion.
- Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the FDA also has had the authority to regulate tobacco products.
- The FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety.
- The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC drug products.
- Cosmetics are regulated by the Center for Food Safety and Applied Nutrition, the same branch of the FDA that regulates food.
- Before the 1990s, only 20% of all drugs prescribed for children in the United States were tested for safety or efficacy in a pediatric population.
- The Center for Veterinary Medicine (CVM) is the branch of the FDA that regulates food, food additives, and drugs that are given to animals, including food animals and pets.
- The Center for Devices and Radiological Health (CDRH) is the branch of the FDA responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.
- The FDA regulates more than US$1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of these expenditures are for goods imported into the United States; the FDA is responsible for monitoring imports.
The FDA has its headquarters at Rockville, Maryland and has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico.
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.
Curated and edited by Ian C. Langtree, Founder & Editor-in-Chief, Disabled World. This section is maintained by the Disabled World editorial team.
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