About FDA - Food and Drug Administration (2023)

FAQs

Why the FDA is important? ›

The FDA is responsible for protecting and promoting public health through regulation and supervision of food safety, dietary supplements, tobacco products, over-the-counter and prescription animal and human medications, vaccines, medical devices, etc.

Listen to pronunciation. (... ad-MIH-nih-STRAY-shun) An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled.

A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.

FDA develops regulations based on the laws set forth in the Food, Drug, and Cosmetic Act (FD&C Act) or other laws – including the Family Smoking Prevention and Tobacco Control Act – under which FDA operates. FDA regulations have the full force of law.

Monitors, evaluates and ensures compliance of manufacturers, distributors, advertisers and retailers of processed foods, drugs and other related products to health rules and regulations and standards of quality.

First, FDA reviews the safety and effectiveness of new drugs that manufacturers2 wish to market in the United States; this process is called premarket approval or preapproval review. Second, once a drug has passed that threshold and is FDA-approved, FDA acts through its postmarket or postapproval regulatory procedures.

On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older.

What are the different types of FDA approval? ›

To give patients earlier access to critical new drugs, four rapid FDA approval designations exist — priority review, breakthrough therapy, accelerated approval, and fast track.

To get FDA approval, drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA. FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.

There are over 19,000 prescription drug products approved for marketing.

FDA Drug-Approval Process. A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA post-market safety monitoring.

DREs classify drugs in one of seven categories: central nervous system (CNS) depressants, CNS stimulants, hallucinogens, dissociative anesthetics, narcotic analgesics, inhalants, and cannabis.

Without FDA review, there is no way to know if these drugs are safe and effective for their intended use, whether they are manufactured in a way that ensures consistent drug quality or whether their label is complete and accurate.

The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.

FDA regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, with the exception of meat, poultry, and certain processed egg products regulated by the U.S. Department of Agriculture (USDA).

The Final Rule states that the responsible party may authorize the National Institutes of Health (NIH) to publicly post clinical trial registration information for an applicable device clinical trial of a device product that has not been previously approved or cleared by the U.S. FDA.

FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. FDA also has the responsibility in maintaining the safety of our nation's food supply (human and animal), cosmetics, and products that emit radiation.

Are FDA requirements law? ›

FDA regulations are also federal laws, but they are not part of the FD&C Act. FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR).

FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”

FDA Approval refers to the list of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA.

The agency regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, except for meat, poultry, certain processed egg products, and catfish, which are regulated by the U.S. Department of Agriculture. The regulatory requirements may depend on the specific nature of your product.

Food and Drug Administration

FDA headquarters facilities are located in Montgomery and Prince Georges Counties in Maryland. Many FDA employees are consolidated at the White Oak Campus located in Silver Spring, MD. Remaining headquarters employees are housed in numerous additional buildings located across the Washington, D.C. area.

The United States Food and Drug Administration (FDA) was first created to enforce the Pure Food and Drug Act of 1906. In this capacity, the FDA is charged with protecting the health of the US public, to ensure the quality of its food, medicine, and cosmetics.

The Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older.

The Pfizer and Moderna vaccines are strongly recommended as safe and effective at preventing serious illness or death from COVID-19. From December 2020 to December 2021, about 470 million doses of COVID-19 vaccine have been given in the U.S.

Reinfection with the virus that causes COVID-19 means a person was infected, recovered, and then later became infected again. After recovering from COVID-19, most individuals will have some protection from repeat infections. However, reinfections do occur after COVID-19.

What is FDA classification? ›

The FDA generally classifies medical devices based on the risks associated with the device and by evaluating the amount of regulation that provides a reasonable assurance of the device's safety and effectiveness. Devices are classified into one of three regulatory classes: class I, class II, or class III.

Registration simply means the FDA is aware of the manufacturer and their devices. The manufacturer cannot claim the device is “FDA Cleared” or “Approved,” and they cannot use the FDA logo in marketing or labeling the device.

Overall success rates from Phase I to FDA approval is nearly 9%. This number is comprised of lead and secondary indications. When separated, lead indications have close to a one in seven rate of approval and secondary indications have a rate of one in 30.

1937. Elixir of Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.

Though FDA can trace its origins back to the creation of the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act.

There are three phases to complete in the clinical trial process before a sponsor can submit their treatments* to the FDA for consideration to be sold on the market. Each stage of a clinical trial has its own purpose in ensuring that a treatment is safe and effective for use by the public.

What is FDA and their responsibility? ›

Monitors, evaluates and ensures compliance of manufacturers, distributors, advertisers and retailers of processed foods, drugs and other related products to health rules and regulations and standards of quality.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The United States Food and Drug Administration (FDA) was first created to enforce the Pure Food and Drug Act of 1906. In this capacity, the FDA is charged with protecting the health of the US public, to ensure the quality of its food, medicine, and cosmetics.

The FDA: Protecting Consumers and Patients

The FDA is there to protect consumers and patients and ensure their safety by regulating and approving products, issuing recalls and safety notices, and alerting us to health scams and other health threats.

First, FDA reviews the safety and effectiveness of new drugs that manufacturers2 wish to market in the United States; this process is called premarket approval or preapproval review. Second, once a drug has passed that threshold and is FDA-approved, FDA acts through its postmarket or postapproval regulatory procedures.

FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

The agency regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, except for meat, poultry, certain processed egg products, and catfish, which are regulated by the U.S. Department of Agriculture. The regulatory requirements may depend on the specific nature of your product.

FDA Approval refers to the list of drugs approved by the Food and Drug Administration (FDA) for sale in the United States. New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA.

What drugs does the FDA regulate? ›

1937. Elixir of Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.

Although it was not known by its present name until 1930, FDA's modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs.

United States

Food and Drug Administration / Jurisdiction