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on this page: What Does FDA Do?
What Does FDA Regulate?
How Is FDA Organized?
What is the difference between the Federal Food,
Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA
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Introduction to FDA
FDA publishes a series of questions and answers which provide a
great introduction to FDA and how it works. They are duplicated below.
See the menu on the left for links to all the questions on this page.
What does FDA do?
FDA is responsible for:
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Protecting the public health by assuring that foods are
safe, wholesome, sanitary and properly labeled; human and veterinary drugs,
and vaccines and other biological products and medical devices intended for
human use are safe and effective
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Protecting the public from electronic product radiation
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Assuring cosmetics and dietary supplements are safe and properly
labeled
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Regulating tobacco products
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Advancing the public health by helping to speed product
innovations
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Helping the public get the accurate science-based information
they need to use medicines, devices, and foods to improve their health
FDA’s responsibilities extend to the 50 United States, the District of Columbia,
Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S.
territories and possessions.
Source:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm .
What does FDA regulate?
FDA regulates:
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foods, except for most meat and poultry products, which
are regulated by the U.S. Department of Agriculture
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food additives
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infant formulas
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dietary supplements
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human drugs
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vaccines, blood products, and other biologics
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medical devices, from simple items like tongue depressors, to
complex technologies such as heart pacemakers
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electronic products that give off radiation, such as microwave
ovens and X-ray equipment
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cosmetics
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feed, drugs, and devices used in pets, farm animals, and other
animals
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tobacco products
Source:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm
How is FDA organized?
FDA is an agency within the U.S. Department of Health and Human
Services2. It consists of six product centers, one research center, and two
offices:
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Center for Biologics Evaluation and Research, which
regulates products such as vaccines, blood, and gene therapy
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Center for Devices and Radiological Health, which regulates
medical devices ranging from thermometers to kidney dialysis machines, and
electronic products that give off radiation, such as microwave ovens
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Center for Drug Evaluation and Research, which regulates
over-the-counter and prescription medications
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Center for Food Safety and Applied Nutrition, which regulates
most foods (except meat and poultry, which are regulated by the U.S. Department
of Agriculture), food additives, infant formulas, dietary supplements, and
cosmetics
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Center for Tobacco Products, which regulates cigarettes,
cigarette tobacco, roll-your-own tobacco, and smokeless tobacco
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Center for Veterinary Medicine, which regulates feed and drugs
and devices used in pets, farm animals, and other animals
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National Center for Toxicological Research9, which supports
FDA’s product centers by providing innovative scientific technology, training,
and technical expertise
Office of Regulatory Affairs10, which conducts inspections and enforces FDA
regulations
Office of the Commissioner11, which provides leadership and direction to FDA’s
product centers, research center, and Office of Regulatory Affairs.
Source:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194884.htm
What is the difference between the Federal Food,
Drug, and Cosmetic Act (FD&C Act), FDA regulations, and FDA
guidance?
The Federal Food, Drug, and Cosmetic Act (FD&C
Act) is a federal law enacted by Congress. It and other federal
laws establish the legal framework within which FDA operates.
The FD&C Act can be found in the United States Code, which
contains all general and permanent U.S. laws, beginning at 21
U.S.C. 301.
FDA develops regulations based on the laws set
forth in the FD&C Act or other laws under which FDA operates.
FDA follows the procedures required by the Administrative
Procedure Act, another federal law, to issue FDA regulations.
This typically involves a process known as "notice and comment
rulemaking" that allows for public input on a proposed
regulation before FDA issues a final regulation. 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
follows the procedures required by its "Good Guidance Practice"
regulation to issue FDA guidance. FDA guidance describes the
agency’s current thinking on a regulatory issue. Guidance is not
legally binding on the public or FDA. The Good Guidance Practice
regulation can be found at
21 CFR 10.115.
Source:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194909.htm
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