The mission of FDA is to enforce laws enacted by the U.S. Congress
and regulations established by the Agency to protect the consumer's health, safety, and
Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S.
With numerous amendments it is the most extensive law of its kind in the world. The
law is intended to assure the consumer that foods are pure and wholesome, safe to eat, and
produced under sanitary conditions; that drugs and devices are safe and effective for
their intended uses; that cosmetics are safe and made from appropriate ingredients; and
that all labeling and packaging is truthful, informative, and not deceptive.
Prescription Drug User Fee Act
(PDUFA): Frequently asked questions (Posted 10/11/2002)
Entity Compliance Guide: Sterility Requirement for Aqueous-Based Drug
Products for Oral Inhalation
(Posted 11/7/2001) This guidance states the
legal requirements requiring that all prescription and over-the counter
(OTC) aqueous-based drug products for oral inhalation
be manufactured sterile.
Laws Enforced by the
FDA. Includes the Federal Food, Drug and Cosmetics Act, the 1997 Modernization
Act, and over 30 other acts, amendments, provisions, and laws.
of Civil Money Penalties for Small Entities. FDA
this final guidance for the reduction of civil money penalties (CMPs)
for small entities (penalty reduction guidance (SBREFA) (Public Law
104-121) and the Presidential Memorandum of April 21, 1995 (60 FR 20621,
April 26, 1995).
of Federal Regulations (CFR) Section 21. The final regulations published in
the Federal Register
(daily published record of proposed rules, final rules, meeting notices, etc.) are
collected in the CFR. The CFR is divided into 50 titles which represent broad areas
subject to Federal regulations. The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic
Act and related statutes. Section 21 of the CFR contains most of the
regulations pertaining to food and drugs. The regulations document all actions of
all drug sponsors that are required under Federal law.
Documents. Guidance documents represent the Agency's current thinking on a
particular subject. Because guidances are not regulations or laws, they are not
enforceable, either through administrative actions or through the courts. An
alternative approach may be used if such approach satisfies the requirements of the
applicable statute, regulations, or both. The FDA Guidance Webpage
provides links to guidances from all five FDA Centers, including the Guidance for Industry
on: Exports and Imports
Under the FDA Export Reform and Enhancement Act of 1996.
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FDA/Center for Drug Evaluation and Research
Last Updated: September 2, 2005
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