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发帖数: 25265 | 1 The 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. The FDA is 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), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic radiation emitting
devices (ERED), veterinary products, and cosmetics.
The FDA also enforces other laws, notably Section 361 of the Public Health
Service Act and associated regulations, many of which are not directly
related to food or drugs. These include sanitation requirements on
interstate travel and control of disease on products ranging from certain
household pets to sperm donation for assisted reproduction.
The FDA is led by the Commissioner of Food and Drugs, appointed by the
President with the advice and consent of the Senate. The Commissioner
reports to the Secretary of Health and Human Services. The 21st and current
Commissioner is Dr. Margaret A. Hamburg. She has served as Commissioner
since February 2009.
The FDA has their headquarters at Silver Spring, Maryland and has 223 field
offices and 13 laboratories located throughout the 50 states, the United
States Virgin Islands, and Puerto Rico.[3] In 2008, the FDA started opening
offices in foreign countries, including China, India, Costa Rica, Chile,
Belgium, and the United Kingdom.[4]
Contents [hide]
1 Organization
2 Scope and funding
3 Legal authority
4 Regulatory programs
4.1 Food and dietary supplements
4.2 Drugs
4.2.1 New drugs
4.2.1.1 Advertising and promotion
4.2.1.2 Postmarket safety surveillance
4.2.2 Generic drugs
4.2.2.1 Generic drug scandal
4.2.3 Over-the-counter drugs
4.3 Vaccines, blood and tissue products, and biotechnology
4.4 Medical and radiation-emitting devices
4.5 Cosmetics
4.6 Cosmetic products
4.7 Veterinary products
4.8 Tobacco products
5 History
5.1 Early history
5.1.1 Origins of federal food and drug regulation
5.1.2 The 1906 Food and Drug Act and creation of the FDA
5.1.3 The 1938 Food, Drug, and Cosmetic Act
5.2 Regulation of human drugs and medical devices after 1938
5.2.1 Early FD&C Act amendments: 1938-1958
5.2.2 Expansion of premarket approval process: 1959-1985
5.2.3 FDA reforms in the AIDS era
5.2.4 Challenges to FDA authority by states
6 Recent and ongoing reforms
6.1 Critical Path Initiative
6.2 Patients' rights to access unapproved drugs
6.3 Post-marketing drug safety monitoring
6.4 Pediatric drug testing
6.5 Rules for generic biologics
7 Criticism
8 Regulation of living organisms
9 See also
10 References
11 Further reading
12 External links
[edit] OrganizationThe FDA comprises several offices and centers. There are
Office of the Commissioner
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health (CDRH)
Office of the Center Director
Office of Communication, Education, and Radiation Programs
Office of Compliance
Office of Device Evaluation
Office of In Vitro Diagnostic Device Evaluation and Safety
Office of Management Operations
Office of Science and Engineering Laboratories
Office of Surveillance and Biometrics
Center for Drug Evaluation and Research (CDER)
Office of the Center Director
Advisory Committee Staff
Controlled Substance Staff
Office of Compliance
Division of Compliance Risk Management and Surveillance
Division of Manufacturing and Product Quality
Division of New Drugs and Labeling Compliance
Division of Scientific Investigations
Office of Medical Policy
Division of Drug Marketing, Advertising and Communications8
Office of New Drugs
Office of Nonprescription Products
Office of Oncology Drug Products
Radioactive Drug Research Committee (RDRC) Program
Office of Pharmaceutical Science
Office of Biotechnology Products
Office of Generic Drugs
Office of New Drugs Quality Assessment
Office of Testing and Research
Division of Applied Pharmacology Research
Division of Pharmaceutical Analysis
Division of Product Quality Research
Informatics and Computational Safety Analysis Staff (ICSAS)
Office of Surveillance and Epidemiology (formerly Office of Drug Safety)
Office of Translational Sciences23
Office of Biostatistics
Office of Clinical Pharmacology
Pharmacometrics Staff
Division of Drug Information
FDA Pharmacy Student Experiential Program
Botanical Review Team
Maternal Health Team
Center for Food Safety and Applied Nutrition
Center for Tobacco Products
Center for Veterinary Medicine
National Center for Toxicological Research
Office of Regulatory Affairs
In recent years, the agency began undertaking a large-scale effort to
consolidate its operations in the Washington Metropolitan Area from its main
headquarters in Rockville and several fragmented office buildings in the
vicinity to the former site of the Naval Ordnance Laboratory in the White
Oak area of Silver Spring, Maryland. When the FDA arrived, the site was
renamed from the White Oak Naval Surface Warfare Center to the Federal
Research Center at White Oak. The first building, the Life Sciences
Laboratory, was dedicated and opened with 104 employees on the campus in
December 2003. The project is slated to be completed by 2013.
While most of the Centers are located around the Washington, D.C., area as
part of the Headquarters divisions, two offices - the Office of Regulatory
Affairs (ORA) and the Office of Criminal Investigations (OCI) - are
primarily field offices with a workforce spread across the country.
The Office of Regulatory Affairs is considered the "eyes and ears" of the
agency, conducting the vast majority of the FDA's work in the field.
Consumer Safety Officers, more commonly called Investigators, are the
individuals who inspect production and warehousing facilities, investigate
complaints, illnesses, or outbreaks, and review documentation in the case of
medical devices, drugs, biological products, and other items where it may
be difficult to conduct a physical examination or take a physical sample of
the product. The Office of Regulatory Affairs is divided into five regions,
which are further divided into 13 districts. Districts are based roughly on
the geographic divisions of the federal court system. Each district
comprises a main district office, and a number of Resident Posts, which are
FDA offices located away from the district office to serve a particular
geographic area. ORA also includes the Agency's network of laboratories,
which analyze any physical samples taken. Though samples are usually food-
related, some laboratories are equipped to analyze drugs, cosmetics, and
radiation-emitting devices.
The Office of Criminal Investigations was established in 1991 to investigate
criminal cases. Unlike ORA Investigators, OCI Special Agents are armed, and
are not focused on the technical aspects of the regulated industries. OCI
agents pursue and develop cases where criminal actions have occurred, such
as fraudulent claims, or knowingly and willfully shipping known adulterated
goods in interstate commerce. In many cases, OCI will pursue cases where
Title 18 violations have occurred (e.g. conspiracy, false statements, wire
fraud, mail fraud), in addition to prohibited acts as defined in Chapter III
of the FD&C Act. OCI Special Agents often come from other criminal
investigations backgrounds, and work closely with the Federal Bureau of
Investigation, Assistant Attorney General, and even Interpol. OCI will
receive cases from a variety of sources, including ORA, local agencies, and
the FBI, and will work with ORA investigators to help develop the technical
and science-based aspects of a case. OCI is a smaller branch, comprising
about 200 agents nationwide.
The FDA frequently works in conjunction with other federal agencies
including the Department of Agriculture, Drug Enforcement Administration,
Customs and Border Protection, and Consumer Product Safety Commission. Often
local and state government agencies also work in cooperation with the FDA
to provide regulatory inspections and enforcement action.
[edit] Scope and fundingThe 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.[5]
The FDA's federal budget request for fiscal year (FY) 2008 (October 2007
through September 2008) totaled $2.1 billion, a $105.8 million increase from
what it received for fiscal year 2007.[6] In February 2008, the FDA
announced that the Bush Administration's FY 2009 budget request for the
agency was just under $2.4 billion: $1.77 billion in budget authority (
federal funding) and $628 million in user fees. The requested budget
authority was an increase of $50.7 million more than the FY 2008 funding -
about a three percent increase. In June 2008, Congress gave the agency an
emergency appropriation of $150 million for FY 2008 and another $150 million
.[5]
This section requires expansion.
[edit] Legal authorityMost federal laws concerning the FDA are part of the
Food, Drug and Cosmetic Act,[7] (first passed in 1938 and extensively
amended since) and are codified in Title 21, Chapter 9 of the United States
Code. Other significant laws enforced by the FDA include the Public Health
Service Act, parts of the Controlled Substances Act, the Federal Anti-
Tampering Act, as well as many others. In many cases these responsibilities
are shared with other federal agencies.
Important enabling legislation for the FDA includes:
1902 – Biologics Control Act
1906 – Pure Food and Drug Act
1938 – Federal Food, Drug, and Cosmetic Act
1944 – Public Health Service Act
1951 – 1951 Food, Drug, and Cosmetics Act Amendments PL 82–215
1962 – 1962 Food, Drug, and Cosmetics Act Amendments PL 87–781
1966 – Fair Packaging and Labeling Act PL 89–755
1976 – Medical Device Regulation Act PL 94–295
1987 – Prescription Drug Marketing Act
1988 – Anti–drug Abuse Act PL 100–690
1990 – Nutrition Labeling and Education Act PL 101–535
1992 – Prescription Drug User Fee Act PL 102–571
1994 – Dietary Supplement Health and Education Act
1997 – Food and Drug Administration Modernization Act 105-115
2002 – Bioterrorism Act 107-188
2002 – Medical Device User Fee and Modernization Act (MDUFMA) PL 107-250
2003 – Animal Drug User Fee Act PL 108-130
2007 – Food and Drug Administration Amendments Act of 2007
2009 – Family Smoking Prevention and Tobacco Control Act
2010 – FDA Food Safety Modernization Act
[edit] Regulatory programsThe 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. The FDA regulates most products with a set
of published standards enforced by a modest number of facility inspections.
Inspection observations are documented on Form 483.
This section requires expansion.
[edit] Food and dietary supplementsMain article: Regulation of food and
dietary supplements by the U.S. Food and Drug Administration
The Center for Food Safety and Applied Nutrition is the branch of the FDA
which is responsible for ensuring the safety and accurate labeling of nearly
all food products in the United States.[8] One exception is meat products
derived from traditional domesticated animals, such as cattle and chickens,
which fall under the jurisdiction of the United States Department of
Agriculture Food Safety and Inspection Service. Products which contain
minimal amounts of meat are regulated by FDA, and the exact boundaries are
listed in a memorandum of understanding between the two agencies. However,
medicines and other products given to all domesticated animals are regulated
by the FDA through a different branch, the Center for Veterinary Medicine.
Other consumables which are not regulated by the FDA include beverages
containing more than 7% alcohol (regulated by the Bureau of Alcohol, Tobacco
, Firearms and Explosives in the Department of Justice), and non-bottled
drinking water (regulated by the United States Environmental Protection
Agency (EPA)).
CFSAN's activities include establishing and maintaining food standards, such
as standards of identity (for example, what the requirements are for a
product to be labeled, "yogurt") and standards of maximum acceptable
contamination. CFSAN also sets the requirements for nutrition labeling of
most foods. Both food standards and nutrition labeling requirements are part
of the Code of Federal Regulations.
The Dietary Supplement Health and Education Act of 1994 mandated that the
FDA regulate dietary supplements as foods, rather than as drugs. Therefore,
dietary supplements are not subject to safety and efficacy testing and there
are no approval requirements. The FDA can take action against dietary
supplements only after they are proven to be unsafe. Manufacturers of
dietary supplements are permitted to make specific claims of health benefits
, referred to as "structure or function claims" on the labels of these
products. They may not claim to treat, diagnose, cure, or prevent disease
and must include a disclaimer on the label.[9]
Bottled water is regulated in America by the FDA.[10] State governments also
regulate bottled water. Tap water is regulated by state and local
regulations, as well as the United States EPA. FDA regulations of bottled
water generally follow the guidelines established by the EPA, and new EPA
rules automatically apply to bottled water if the FDA does not release an
explicit new rule.[11]
[edit] DrugsRegulation of therapeutic goods in the United States
Prescription drugs
Over-the-counter drugs [show]Law
Federal Food, Drug, and Cosmetic Act
Comprehensive Drug Abuse Prevention and Control Act of 1970
Controlled Substances Act
Prescription Drug Marketing Act
Drug Price Competition and Patent Term Restoration Act
Hatch-Waxman exemption
[show]Government agencies
United States Department of Health and Human Services
Food and Drug Administration
Drug Enforcement Administration
Center for Drug Evaluation and Research
[show]Process
Drug discovery
Drug design
Drug development
New drug application
Investigational new drug
Clinical trial (Phase I, II, III, IV)
Randomized controlled trial
Pharmacovigilance
Abbreviated New Drug Application
Fast track approval
Off-label use
[show]International coordination
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use
Uppsala Monitoring Centre
World Health Organization
Council for International Organizations of Medical Sciences
Single Convention on Narcotic Drugs
[show]Non-governmental organizations.
Institute of Medicine
Research on Adverse Drug events And Reports
v · d · e
The Center for Drug Evaluation and Research has different requirements for
the three main types of drug products: new drugs, generic drugs and over-the
-counter drugs. A drug is considered "new" if it is made by a different
manufacturer, uses different excipients or inactive ingredients, is used for
a different purpose, or undergoes any substantial change. The most rigorous
requirements apply to "new molecular entities": drugs which are not based
on existing medications.
[edit] New drugsNew 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."
[edit] Advertising and promotionThe FDA reviews and regulates prescription
drug advertising and promotion. (Other kinds of advertising, including for
over-the-counter drugs, are regulated by the Federal Trade Commission). The
drug advertising regulation[12] contains two key requirements. Under most
circumstances, a company may only advertise a drug for the specific
indication or medical use for which it was approved. Also, an advertisement
must contain "fair balance" between the benefits and risks of a drug.
The term "off-label" refers to drug usage for indications other than those
approved by the FDA.
[edit] Postmarket safety surveillanceAfter approval of an NDA, the sponsor
must review and report to the FDA every patient adverse drug experience of
which it learns. Unexpected serious and fatal adverse drug events must be
reported within 15 days, and other events on a quarterly basis.[13] The FDA
also receives directly adverse drug event reports through its MedWatch
program.[14] These reports are called "spontaneous reports" because
reporting by consumers and health professionals is voluntary. While this
remains the primary tool of postmarket safety surveillance, FDA requirements
for postmarketing risk management are increasing. As a condition of
approval, a sponsor may be required to conduct additional clinical trials,
called Phase IV trials. In some cases, the FDA requires risk management
plans for some drugs that may provide for other kinds of studies,
restrictions, or safety surveillance activities.
[edit] Generic drugsGeneric drugs are chemical equivalents of name-brand
drugs whose patents have expired.[15] 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.[15] For approval of a generic
drug, the U.S. Food and Drug Administration (FDA) requires scientific
evidence that the generic drug is interchangeable with or therapeutically
equivalent to the originally approved drug.[16] This is called an "ANDA" (
Abbreviated New Drug Application).
[edit] Generic drug scandalIn 1989, a major scandal erupted involving the
procedures used by the FDA to approve generic drugs for sale to the public.[
15] Charges of corruption in generic drug approval first emerged in 1988, in
the course of an extensive congressional investigation into the FDA. The
oversight subcommitee of the United States House Energy and Commerce
Committee resulted from a complaint brought against the FDA by Mylan
Laboratories Inc. of Pittsburgh. When its application to manufacture
generics were subjected to repeated delays by the FDA, Mylan, convinced that
it was being discriminated against, soon began its own private
investigation of the agency in 1987. Mylan eventually filed suit against two
former FDA employees and four drug-manufacturing companies, charging that
corruption within the federal agency resulted in racketeering and in
violations of antitrust law. "The order in which new generic drugs were
approved was set by the FDA employees even before drug manufacturers
submitted applications" and, according to Mylan, this illegal procedure was
followed to give preferential treatment to certain companies. During the
summer of 1989, three FDA officials pleaded guilty to criminal charges of
accepting bribes from generic drugs makers, and two companies pleaded guilty
to giving bribes. Furthermore, it was discovered that several manufacturers
had falsified data submitted in seeking FDA authorization to market certain
generic drugs. Vitarine Pharmaceuticals of New York, which sought approval
of a generic version of the drug Dyazide, a medication for high blood
pressure, submitted Dyazide, rather than its generic version, for the FDA
tests. In April 1989, the FDA investigated 11 manufacturers for
irregularities; and later brought that number up to 13. Dozens of drugs were
eventually suspended or recalled by manufacturers. In the early 1990s, the
U.S. Securities and Exchange Commission filed "securities fraud charges
against the Bolar Pharmaceutical Company, a major generic manufacturer based
in Long Island, New York.[15]
[edit] Over-the-counter drugsOver-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.[17]
[edit] Vaccines, blood and tissue products, and biotechnologyThe Center for
Biologics Evaluation and Research is the branch of the FDA responsible for
ensuring the safety and efficacy of biological therapeutic agents.[18] These
include blood and blood products, vaccines, allergenics, cell and tissue-
based products, and gene therapy products. New biologics are required to go
through a premarket approval process similar to that for drugs. The original
authority for government regulation of biological products was established
by the 1902 Biologics Control Act, with additional authority established by
the 1944 Public Health Service Act. Along with these Acts, the Federal Food,
Drug, and Cosmetic Act applies to all biologic products, as well.
Originally, the entity responsible for regulation of biological products
resided under the National Institutes of Health; this authority was
transferred to the FDA in 1972.
[edit] Medical and radiation-emitting devicesThe 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.[19] The definition
of a medical device is given in the FD&C Act, and it includes products from
the simple toothbrush to complex devices such as implantable brain
pacemakers. CDRH also oversees the safety performance of non-medical devices
which emit certain types of electromagnetic radiation. Examples of CDRH-
regulated devices include cellular phones, airport baggage screening
equipment, television receivers, microwave ovens, tanning booths, and laser
products.
CDRH regulatory powers include the authority to require certain technical
reports from the manufacturers or importers of regulated products, to
require that radiation-emitting products meet mandatory safety performance
standards, to declare regulated products defective, and to order the recall
of defective or noncompliant products. CDRH also conducts limited amounts of
direct product testing.
[edit] CosmeticsCosmetics are regulated by the Center for Food Safety and
Applied Nutrition, the same branch of the FDA that regulates food. Cosmetic
products are not generally subject to premarket approval by the FDA unless
they make "structure or function claims", which make them into drugs (see
Cosmeceutical). However, all color additives must be specifically approved
by the FDA before they can be included in cosmetic products sold in the U.S.
The labelling of cosmetics is regulated by the FDA, and cosmetics which
have not been subjected to thorough safety testing must bear a warning to
that effect.
[edit] Cosmetic productsThough the cosmetic industry is predominantly
responsible in ensuring the safety of its products, the FDA also has the
power to intervene when necessary to protect the public but does not
generally require pre-market approval or testing. Companies are required to
place a warning note on their products if they have not been tested. Experts
in cosmetic ingredient reviews also play a role in monitoring safety
through influence on the use of ingredients, but also lack legal authority.
Overall the organization has reviewed about 1,200 ingredients and has
suggested that several hundred be restricted, but there is no standard or
systemic method for reviewing chemicals for safety and a clear definition of
what is meant by ‘safety’ so that all chemicals are tested on the same
basis.[20]
[edit] Veterinary productsThe Center for Veterinary Medicine (CVM) is the
branch of the FDA which regulates food, food additives, and drugs that are
given to animals, including food animals and pets. CVM does not regulate
vaccines for animals; these are handled by the United States Department of
Agriculture.
CVM's primary focus is on medications that are used in food animals and
ensuring that they do not affect the human food supply. The FDA's
requirements to prevent the spread of bovine spongiform encephalopathy are
also administered by CVM through inspections of feed manufacturers.
[edit] Tobacco productsSince the Family Smoking Prevention and Tobacco
Control Act became law in 2009, the FDA also has had the authority to
regulate tobacco products.[21]
[edit] History[edit] Early history[edit] Origins of federal food and drug
regulationUp until the 20th century, there were few federal laws regulating
the contents and sale of domestically produced food and pharmaceuticals,
with one exception being the short-lived Vaccine Act of 1813. A patchwork of
state laws provided varying degrees of protection against unethical sales
practices, such as misrepresenting the ingredients of food products or
therapeutic substances. The history of the FDA can be traced to the latter
part of the 19th century and the U.S. Department of Agriculture's Division
of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley,
appointed chief chemist in 1883, the Division began conducting research into
the adulteration and misbranding of food and drugs on the American market.
Although they had no regulatory powers, the Division published its findings
from 1887 to 1902 in a ten-part series entitled Foods and Food Adulterants.
Wiley used these findings, and alliances with diverse organizations such as
state regulators, the General Federation of Women's Clubs, and national
associations of physicians and pharmacists, to lobby for a new federal law
to set uniform standards for food and drugs to enter into interstate
commerce. Wiley's advocacy came at a time when the public had become aroused
to hazards in the marketplace by muckraking journalists like Upton Sinclair
, and became part of a general trend for increased federal regulations in
matters pertinent to public safety during the Progressive Era.[22] The 1902
Biologics Control Act was put in place after diphtheria antitoxin was
collected from a horse named Jim who contracted tetanus, resulting in
several deaths.
[edit] The 1906 Food and Drug Act and creation of the FDAIn June 1906,
President Theodore Roosevelt signed into law the Food and Drug Act, also
known as the "Wiley Act" after its chief advocate.[22] The Act prohibited,
under penalty of seizure of goods, the interstate transport of food which
had been "adulterated", with that term referring to the addition of fillers
of reduced "quality or strength", coloring to conceal "damage or inferiority
," formulation with additives "injurious to health," or the use of "filthy,
decomposed, or putrid" substances. The act applied similar penalties to the
interstate marketing of "adulterated" drugs, in which the "standard of
strength, quality, or purity" of the active ingredient was not either stated
clearly on the label or listed in the United States Pharmacopoeia or the
National Formulary. The act also banned "misbranding" of food and drugs.[23]
The responsibility for examining food and drugs for such "adulteration" or
"misbranding" was given to Wiley's USDA Bureau of Chemistry.[22]
Wiley used these new regulatory powers to pursue an aggressive campaign
against the manufacturers of foods with chemical additives, but the
Chemistry Bureau's authority was soon checked by judicial decisions, as well
as by the creation of the Board of Food and Drug Inspection and the Referee
Board of Consulting Scientific Experts as separate organizations within the
USDA in 1907 and 1908 respectively. A 1911 Supreme Court decision ruled
that the 1906 act did not apply to false claims of therapeutic efficacy,[24]
in response to which a 1912 amendment added "false and fraudulent" claims
of "curative or therapeutic effect" to the Act's definition of "misbranded."
However, these powers continued to be narrowly defined by the courts, which
set high standards for proof of fraudulent intent.[22] In 1927, the Bureau
of Chemistry's regulatory powers were reorganized under a new USDA body, the
Food, Drug, and Insecticide organization. This name was shortened to the
Food and Drug Administration (FDA) three years later.[25]
[edit] The 1938 Food, Drug, and Cosmetic ActBy the 1930s, muckraking
journalists, consumer protection organizations, and federal regulators began
mounting a campaign for stronger regulatory authority by publicizing a list
of injurious products which had been ruled permissible under the 1906 law,
including radioactive beverages, cosmetics which caused blindness, and
worthless "cures" for diabetes and tuberculosis. The resulting proposed law
was unable to get through the Congress of the United States for five years,
but was rapidly enacted into law following the public outcry over the 1937
Elixir Sulfanilamide tragedy, in which over 100 people died after using a
drug formulated with a toxic, untested solvent. The only way that the FDA
could even seize the product was due to a misbranding problem: an "Elixir"
was defined as a medication dissolved in ethanol, not the diethylene glycol
used in the Elixir Sulfanilamide.
President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic
Act (FD&C Act) into law on June 24, 1938. The new law significantly
increased federal regulatory authority over drugs by mandating a pre-market
review of the safety of all new drugs, as well as banning false therapeutic
claims in drug labeling without requiring that the FDA prove fraudulent
intent. The law also authorized factory inspections and expanded enforcement
powers, set new regulatory standards for foods, and brought cosmetics and
therapeutic devices under federal regulatory authority. This law, though
extensively amended in subsequent years, remains the central foundation of
FDA regulatory authority to the present day.[22]
[edit] Regulation of human drugs and medical devices after 1938[edit] Early
FD&C Act amendments: 1938-1958Soon after passage of the 1938 Act, the FDA
began to designate certain drugs as safe for use only under the supervision
of a medical professional, and the category of "prescription-only" drugs was
securely codified into law by the 1951 Durham-Humphrey Amendment.[22] While
pre-market testing of drug efficacy was not authorized under the 1938 FD&C
Act, subsequent amendments such as the Insulin Amendment and Penicillin
Amendment did mandate potency testing for formulations of specific
lifesaving pharmaceuticals.[25] The FDA began enforcing its new powers
against drug manufacturers who could not substantiate the efficacy claims
made for their drugs, and the United States Court of Appeals for the Ninth
Circuit ruling in Alberty Food Products Co. v. United States (1950) found
that drug manufacturers could not evade the "false therapeutic claims"
provision of the 1938 act by simply omitting the intended use of a drug from
the drug's label. These developments confirmed extensive powers for the FDA
to enforce post-marketing recalls of ineffective drugs.[22] Much of the FDA
's regulatory attentions in this era were directed towards abuse of
amphetamines and barbiturates, but the agency also reviewed some 13,000 new
drug applications between 1938 and 1962. While the science of toxicology was
in its infancy at the start of this era, rapid advances in experimental
assays for food additive and drug safety testing were made during this
period by FDA regulators and others.[22]
[edit] Expansion of premarket approval process: 1959-1985In 1959, Senator
Estes Kefauver began holding congressional hearings into concerns about
pharmaceutical industry practices, such as the perceived high cost and
uncertain efficacy of many drugs promoted by manufacturers. There was
significant opposition, however, to calls for a new law expanding the FDA's
authority. This climate was rapidly changed by the thalidomide tragedy, in
which thousands of European babies were born deformed after their mothers
took that drug - marketed for treatment of nausea - during their pregnancies
. Thalidomide had not been approved for use in the U.S. due to the concerns
of an FDA reviewer, Frances Oldham Kelsey, about thyroid toxicity. However,
thousands of "trial samples" had been sent to American doctors during the "
clinical investigation" phase of the drug's development, which at the time
was entirely unregulated by the FDA. Individual members of Congress cited
the thalidomide incident in lending their support to expansion of FDA
authority.[26]
The 1962 Kefauver-Harris Amendment to the FD&C act represented a "revolution
" in FDA regulatory authority.[27] The most important change was the
requirement that all new drug applications demonstrate "substantial evidence
" of the drug's efficacy for a marketed indication, in addition to the
existing requirement for pre-marketing demonstration of safety. This marked
the start of the FDA approval process in its modern form. Drugs approved
between 1938 and 1962 were also subject to FDA review of their efficacy, and
to potential withdrawal from the market. Other important provisions of the
1962 amendments included the requirement that drug companies use the "
established" or "generic" name of a drug along with the trade name, the
restriction of drug advertising to FDA-approved indications, and expansion
of FDA powers to inspect drug manufacturing facilities.
These reforms had the effect of increasing the time required to bring a drug
to market.[28] In the mid-1970s, 13 of the 14 drugs the FDA saw as most
important to approve were on the market in other countries before the United
States.[28]
One of the most important statutes in establishing the modern American
pharmaceutical market was the 1984 Drug Price Competition and Patent Term
Restoration Act, more commonly known as the "Hatch-Waxman Act" after its
chief sponsors. This act was intended to correct two unfortunate
interactions between the new regulations mandated by the 1962 amendments,
and existing patent law (which is not regulated or enforced by the FDA, but
rather by the United States Patent and Trademark Office). Because the
additional clinical trials mandated by the 1962 amendments significantly
delayed the marketing of new drugs, without extending the duration of the
manufacturer's patent, "pioneer" drug manufacturers experienced a decreased
period of lucrative market exclusivity. On the other hand, the new
regulations could be interpreted to require complete safety and efficacy
testing for generic copies of approved drugs, and "pioneer" manufacturers
obtained court decisions which prevented generic manufacturers from even
beginning the clinical trial process while a drug was still under patent.
The Hatch-Waxman Act was intended as a compromise between the "pioneer" and
generic drug manufacturers which would reduce the overall cost of bringing
generics to market and thus, it was hoped, reduce the long-term price of the
drug, while preserving the overall profitability of developing new drugs.
The act extended the patent exclusivity terms of new drugs, and importantly
tied those extensions, in part, to the length of the FDA approval process
for each individual drug. For generic manufacturers, the Act created a new
approval mechanism, the Abbreviated New Drug Application (ANDA), in which
the generic drug manufacturer need only demonstrate that their generic
formulation has the same active ingredient, route of administration, dosage
form, strength, and pharmacokinetic properties ("bioequivalence") as the
corresponding brand-name drug. This act has been credited with essentially
creating the modern generic drug industry.[29]
[edit] FDA reforms in the AIDS eraConcerns about the length of the drug
approval process were brought to the fore early in the AIDS epidemic. In the
mid- and late 1980s, ACT-UP and other HIV activist organizations accused
the FDA of unnecessarily delaying the approval of medications to fight HIV
and opportunistic infections, and staged large protests, such as a
confrontational October 11, 1988 action at the FDA campus which resulted in
nearly 180 arrests.[30] In August 1990, Dr. Louis Lasagna, then chairman of
a presidential advisory panel on drug approval, estimated that thousands of
lives were lost each year due to delays in approval and marketing of drugs
for cancer and AIDS.[31]
Partly in response to these criticisms, the FDA issued new rules to expedite
approval of drugs for life threatening diseases, and expanded pre-approval
access to drugs for patients with limited treatment options.[32] The first
of these new rules was the "IND exemption" or "treatment IND" rule, which
allowed expanded access to a drug undergoing phase II or III trials (or in
extraordinary cases even earlier) if it potentially represented a safer or
better alternative to treatments currently available for terminal or serious
illness. A second new rule, the "parallel track policy", allowed a drug
company to set up a mechanism for access to a new potentially lifesaving
drug by patients who for various reasons would be unable to participate in
ongoing clinical trials. The "parallel track" designation could be made at
the time of IND submission. The accelerated approval rules were further
expanded and codified in 1992.[33]
All of the initial drugs approved for the treatment of HIV/AIDS were
approved through accelerated approval mechanisms. For example, a "treatment
IND" was issued for the first HIV drug, AZT, in 1985, and approval was
granted just two years later in 1987.[34] Three of the first five drugs
targeting HIV were approved in the United States before they were approved
in any other country.[citation needed]
[edit] Challenges to FDA authority by statesIn two instances, state
governments have sought to legalize drugs which have not been approved by
the FDA. Because federal law passed pursuant to Constitutional authority
overrules conflicting state laws, federal authorities still claim the
authority to seize, arrest, and prosecute for possession and sales of these
substances, even in states where they are legal under state law.
The first wave was the legalization by 27 states of laetrile in the late
1970s. This drug was used as a treatment for cancer, but scientific studies
both before and after this legislative trend found it to be ineffective.[35]
[36] Federal law enforcement prevented interstate shipment, making the drug
infeasible to manufacture and sell. Further studies based on a Mexican
formulation also showed no effectiveness in treating cancer, but did find
that some patients experienced symptoms of cyanide poisoning. Though the
political movement died out in the 1980s, FDA enforcement actions against
laetrile purveyors continued into the 2000s.[36]
The second wave concerned medical marijuana in the 1990s and 2000s. Though
Virginia passed a law with limited effect in 1979, a more widespread trend
began in California in 1996. The Obama Administration de-prioritized
enforcement of federal law against patients using the drug in compliance
with state law, resulting in a de facto legalization. Recreational marijuana
remains illegal (but not necessarily criminal) in all states and at the
federal level, as of 2009.
Further information: Medical cannabis in the United States
[edit] Recent and ongoing reforms[edit] Critical Path InitiativeThe Critical
Path Initiative[37] is FDA's effort to stimulate and facilitate a national
effort to modernize the sciences through which FDA-regulated products are
developed, evaluated, and manufactured. The Initiative was launched in March
2004, with the release of a report entitled Innovation/Stagnation:
Challenge and Opportunity on the Critical Path to New Medical Products.[38]
[edit] Patients' rights to access unapproved drugsA 2006 court case, Abigail
Alliance v. von Eschenbach, would have forced radical changes in FDA
regulation of unapproved drugs. The Abigail Alliance argued that the FDA
must license drugs for use by terminally ill patients with "desperate
diagnoses," after they have completed Phase I testing.[39] The case won an
initial appeal in May 2006, but that decision was reversed by a March 2007
rehearing. The US Supreme Court declined to hear the case, and the final
decision denied the existence of a right to unapproved medications.
Critics of the FDA's regulatory power argue that the FDA takes too long to
approve drugs that might ease pain and human suffering faster if brought to
market sooner. The AIDS crisis created some political efforts to streamline
the approval process. However, these limited reforms were targeted for AIDS
drugs, not for the broader market. This has led to the call for more robust
and enduring reforms that would allow patients, under the care of their
doctors, access to drugs that have passed the first round of clinical trials
.[40]
[edit] Post-marketing drug safety monitoring This article is outdated.
Please update this article to reflect recent events or newly available
information. Please see the talk page for more information. (April 2009)
The widely publicized recall of Vioxx, a non-steroidal anti-inflammatory
drug now estimated to have contributed to fatal heart attacks in thousands
of Americans, played a strong role in driving a new wave of safety reforms
at both the FDA rulemaking and statutory levels. Vioxx was approved by the
FDA in 1999, and was initially hoped to be safer than previous NSAIDs, due
to its reduced risk of intestinal tract bleeding. However, a number of pre-
and post-marketing studies suggested that Vioxx might increase the risk of
myocardial infarction, and this was conclusively demonstrated by results
from the APPROVe trial in 2004.[41] Faced with numerous lawsuits, the
manufacturer voluntarily withdrew it from the market. The example of Vioxx
has been prominent in an ongoing debate over whether new drugs should be
evaluated on the basis of their absolute safety, or their safety relative to
existing treatments for a given condition. In the wake of the Vioxx recall,
there were widespread calls by major newspapers, medical journals, consumer
advocacy organizations, lawmakers, and FDA officials[42] for reforms in the
FDA's procedures for pre- and post- market drug safety regulation.
In 2006, a congressionally requested committee was appointed by the
Institute of Medicine to review pharmaceutical safety regulation in the U.S.
and to issue recommendations for improvements. The committee was composed
of 16 experts, including leaders in clinical medicinemedical research,
economics, biostatistics, law, public policy, public health, and the allied
health professions, as well as current and former executives from the
pharmaceutical, hospital, and health insurance industries. The authors found
major deficiencies in the current FDA system for ensuring the safety of
drugs on the American market. Overall, the authors called for an increase in
the regulatory powers, funding, and independence of the FDA.[43][44] Some
of the committee’s recommendations have been incorporated into drafts of
the PDUFA IV bill which was signed into law in 2007.[45]
[edit] Pediatric drug testingPrior to the 1990s, only 20% of all drugs
prescribed for children in the United States were tested for safety or
efficacy in a pediatric population. This became a major concern of
pediatricians as evidence accumulated that the physiological response of
children to many drugs differed significantly from those drugs' effects on
adults. There were several reasons that not many medical trials were done
with children. For many drugs, children represented such a small proportion
of the potential market, that drug manufacturers did not see such testing as
cost-effective. Also, because children were thought to be ethically
restricted in their ability to give informed consent, there were increased
governmental and institutional hurdles to approval of these clinical trials,
as well as greater concerns about legal liability. Thus, for decades, most
medicines prescribed to children in the U.S. were done so in a non-FDA-
approved, "off-label" manner, with dosages "extrapolated" from adult data
through body weight and body-surface-area calculations.[46]
An initial attempt by the FDA to address this issue was the 1994 FDA Final
Rule on Pediatric Labeling and Extrapolation, which allowed manufacturers to
add pediatric labeling information, but required drugs which had not been
tested for pediatric safety and efficacy to bear a disclaimer to that effect
. However, this rule failed to motivate many drug companies to conduct
additional pediatric drug trials. In 1997, the FDA proposed a rule to
require pediatric drug trials from the sponsors of New Drug Applications.
However, this new rule was successfully preempted in Federal court as
exceeding the FDA's statutory authority. While this debate was unfolding,
Congress used the 1997 Food and Drug Administration Modernization Act to
pass incentives which gave pharmaceutical manufacturers a six-month patent
term extension on new drugs submitted with pediatric trial data. The act
reauthorizing these provisions, the 2002 Best Pharmaceuticals for Children
Act, allowed the FDA to request NIH-sponsored testing for pediatric drug
testing, although these requests are subject to NIH funding constraints.
Most recently, in the Pediatric Research Equity Act of 2003, Congress
codified the FDA's authority to mandate manufacturer-sponsored pediatric
drug trials for certain drugs as a "last resort" if incentives and publicly
funded mechanisms proved inadequate.[46]
[edit] Rules for generic biologicsSince the 1990s, many successful new drugs
for the treatment of cancer, autoimmune diseases, and other conditions have
been protein-based biotechnology drugs, regulated by the Center for
Biologics Evaluation and Research. Many of these drugs are extremely
expensive; for example, the anti-cancer drug Avastin costs $55,000 for a
year of treatment, while the enzyme replacement therapy drug Cerezyme costs
$200,000 per year, and must be taken by Gaucher's Disease patients for life.
Biotechnology drugs do not have the simple, readily verifiable chemical
structures of conventional drugs, and are produced through complex, often
proprietary techniques, such as transgenic mammalian cell cultures. Because
of these complexities, the 1984 Hatch-Waxman Act did not include biologics
in the Abbreviated New Drug Application (ANDA) process, essentially
precluding the possibility of generic drug competition for biotechnology
drugs. In February 2007, identical bills were introduced into the House to
create an ANDA process for the approval of generic biologics, but were not
passed.[47]
[edit] CriticismMain article: Criticism of the Food and Drug Administration
Wikinews has related news: Obama calls food safety system a 'hazard to
public health'
The FDA currently has regulatory oversight over a large array of products
that affect the health and life of American citizens.[22] As a result, the
FDA's powers and decisions are carefully monitored by several governmental
and non-governmental organizations. A $1.8 million 2006 Institute of
Medicine report on pharmaceutical regulation in the U.S. found major
deficiencies in the current FDA system for ensuring the safety of drugs on
the American market. Overall, the authors called for an increase in the
regulatory powers, funding, and independence of the FDA.[48][49]
Nine FDA scientists appealed to then president-elect Barack Obama over
pressures from management, experienced during the George W. Bush presidency,
to manipulate data, including in relation to the review process for medical
devices. Characterized as "corrupted and distorted by current FDA managers,
thereby placing the American people at risk," these concerns were also
highlighted in the 2006 report[48] on the agency as well.[50]
The FDA has also been criticized from the opposite viewpoint, as being too
tough on industry. According to an analysis published on the website of the
libertarian Mercatus Center as well as published statements by economists,
medical practitioners, and concerned consumers, many feel the FDA oversteps
its regulatory powers and undermines small business and small farms in favor
of large corporations. Three of the FDA restrictions under analysis are the
permitting of new drugs and devices, the control of manufacturer speech,
and the imposition of prescription requirements. The authors argue that in
the increasingly complex and diverse food marketplace, the FDA is not
equipped to adequately regulate or inspect food.[51]
However, in an indicator that the FDA may be too lax in their approval
process, particularly for medical devices, a 2011 study by Dr. Diana
Zuckerman and Paul Brown of the National Research Center for Women and
Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the
Archives of Internal Medicine, showed that most medical devices recalled in
the last five years for “serious health problems or death” had been
previously approved by the FDA using the less stringent, and cheaper, 501(k)
process. In a few cases the devices had been deemed so low-risk that they
did not need FDA regulation. Of the 113 devices recalled, 35 were for
cardiovacular health purposes.[52]
The FDA had moved for the burning of William Reich's books and research
materials in 1956, which is seen as arguably one of the worst examples of
censorship in U.S. history.[53][54]
[edit] Regulation of living organismsWith acceptance of premarket
notification 510(k) k033391 in January 2004, the FDA granted Dr. Ronald
Sherman permission to produce and market medical maggots for use in humans
or other animals as a prescription medical device. Medical maggots represent
the first living organism allowed by the Food and Drug Administration for
production and marketing as a prescription medical device.
In June 2004, the FDA cleared Hirudo medicinalis (medicinal leeches) as the
second living organism to be used as a medical devices.
[edit] See also Government of the United States portal
Food portal
Medicine portal
100,000,000 Guinea Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics (
book)
Criticism of the Food and Drug Administration
Drug Efficacy Study Implementation
European Medicines Agency
FDA Food Safety Modernization Act
Food Administration[disambiguation needed]
Food and Drug Administration Amendments Act of 2007
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH)
Investigational Device Exemption
Kefauver Harris Amendment
Medicines and Healthcare products Regulatory Agency (UK)
Pharmaceutical company
The Food Defect Action Levels, an FDA publication
[edit] References1.^ "FDA Centennial 1906-2006". US FDA. http://www.fda.gov/centennial/. Retrieved 2008-09-13.
2.^ "FDA commissioner". US FDA. http://www.fda.gov/oc/commissioners/hamburg.html. Retrieved 2009-05-27.
3.^ "FDA 2008 ORA Field Activities" (PDF). USFDA. http://www.fda.gov/oc/oms/ofm/budget/2009/Narratives/8_ORA.pdf. Retrieved 2008-09-13. [dead link]
4.^ "FDA's International Posts: Improving the Safety of Imported Food and
Medical Products". USFDA. http://test.fda.gov/ForConsumers/ConsumerUpdates/ucm185769.htm. Retrieved 2010-04-10.
5.^ a b Gardiner Harris (November 2, 2008). "The Safety Gap". New York Times
Magazine. http://www.nytimes.com/2008/11/02/magazine/02fda-t.html.
6.^ Summary of FDA’s FY 2008 Budget
7.^ Food, Drug and Cosmetic Act Web Version
8.^ Overview of the Center for Food Safety and Applied Nutrition
9.^ Text of the Dietary Supplement Health and Education Act of 1994.
Accessed 5 February 2007.
10.^ Akamaitech.netPDF (106 KB) Title 21 of the Code of Federal regulations
11.^ 217 KB[dead link]
12.^ 21 CFR 202: Prescription Drug Advertising.
13.^ 21 CFR 314.80: Postmarketing Reporting of Adverse Drug Experiences
14.^ MedWatch: The FDA Safety Information and Adverse Event Reporting
Program. Accessed October 9, 2007
15.^ a b c d Cohen, Lynne. "Government Policies and Programs - United States
- Generic Drug Scandal." The New Book of Knowledge - Medicine And Health.
1990. 276-81. ISBN 0-7172-8244-9.
16.^ "Therapeutic Equivalence of Generic Drugs". U.S. Food and Drug
Administration. 1998. Archived from the original on 2007-09-09. http://web.archive.org/web/20070909162853/http://www.fda.gov/cder/news/nightgenlett.htm. Retrieved 2007-10- 10.
17.^ FDA CDER Handbook: Over-the- Counter Drug Products. Accessed October 9,
2007[dead link]
18.^ FDA/CBER - About CBER
19.^ 2005 report of the CDRH Radiological Health Program Core GroupPDF (90.3
KB)
20.^ Ross G (2006). "A perspective on the safety of cosmetic products: a
position paper of the American Council on Science and Health". Int. J.
Toxicol. 25 (4): 269–77. doi:10.1080/10915810600746049. PMID 16815815.
21.^ Does FDA have the authority to regulate tobacco products? Food and Drug
Administration.
22.^ a b c d e f g h i A History of the FDA
23.^ Original Text of the 1906 Food and Drugs Act and Amendments
24.^ United States v. Johnson (1911), 221 U.S. 488 (31 S. Ct. 627 May 29,
1911, decided). 6df1b297de555a5c Text
25.^ a b Milestones in U.S. Food and Drug Law History
26.^ Report of Congressman Morris Udall on thalidomide and the Kefauver
hearings.
27.^ Temple R (2002). "Policy developments in regulatory approval".
Statistics in Medicine 21 (19): 2939–2948. doi:10.1002/sim.1298. PMID
12325110.
28.^ a b Frum, David (2000). How We Got Here: The '70s. New York, New York:
Basic Books. p. 180. ISBN 0465041957.
29.^ Karki L (2005). "Review of FDA Law Related to Pharmaceuticals: The
Hatch-Waxman Act, Regulatory Amendments and Implications for Drug Patent
Enforcement". Journal of the Patent & Trademark Office Society 87: 602–620.
30.^ ACT-UP NY timeline
31.^ Faster Approval of AIDS Drugs Is Urged, The New York Times, August 16,
1990, Thursday, Late Edition - Final, Section B; Page 12, Column 4; National
Desk, 830 words, By ROBERT PEAR, Special to The New York Times, Washington,
Aug. 15
32.^ FDA Website: Expanded Access and Expedited Approval of New Therapies
Related to HIV/AIDS
33.^ Orlando V (1999). "The FDA's Accelerated Approval Process: Does the
Pharmaceutical Industry Have Adequate Incentives for Self-Regulation?".
American Journal of Law and Medicine 25 (4): 543–68. PMID 10629734.
34.^ FDA report on accelerated approval process
35.^ NPR.org
36.^ a b Quackwatch.com
37.^ FDA.gov
38.^ FDA.org
39.^ Abigail Alliance Citizen Petition to FDAPDF (119 KB)
40.^ Amazon.com
41.^ The APPROVe study (Pubmed)
42.^ David Graham's 2004 testimony to CongressPDF (28.3 KB)
43.^ Henderson, Diedtra (2006-09-23). "Panel: FDA needs more power, funds".
Boston Globe. Webcitation.org
44.^ Books.nap.eduPDF (279 KB) Executive Summary of the 2006 IOM Report The
Future of Drug Safety: Promoting and Protecting the Health of the Public
45.^ The PDUFA IV Act
46.^ a b Politis P (2005). "Transition From the Carrot to the Stick: The
Evolution of Pharmaceutical Regulations Concerning Pediatric Drug Testing".
Widener Law Review 12: 271.
47.^ H.R. 1038 Access to Life-Saving Medicine Act
48.^ a b Henderson, Diedtra (September 23, 2006). Panel: FDA needs more
power, funds. Webcitation.org
49.^ Committee on the Assessment of the US Drug Safety System. (2006). The
Future of Drug Safety: Promoting and Protecting the Health of the Public.
Institute of Medicine. Free full-text.
50.^ Mundy A, Favole JA (200). "FDA Scientists Ask Obama to Restructure Drug
Agency". Wall Street Journal. http://online.wsj.com/article/SB123142562104564381.html.
51.^ Williams, Richard, Robert Scharff, and David Bieler (February 2010). "
Food Safety in the 21st Century". Mercatus On Policy. p. 71. http://mercatus.org/publication/food-safety-21st-century.
52.^ [1]
53.^ "Wilhelm Reich," Encyclopaedia Britannica. Retrieved July 26, 2009.
54.^ Biography, The Wilhelm Reich Museum. Retrieved March 15, 2011.
[edit] Further reading | l*****f
发帖数: 359 | 2 wow, this is really long
but i was able to skim it in 2 seconds
【在 s**********8 的大作中提到】
: The 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. The FDA is 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), vaccines, biopharmaceuticals,
: blood transfusions, medical devices, electromagnetic radiation emitting
: devices (ERED), veterinary products, and cosmetics.
: The FDA also enforces other laws, notably Section 361 of the Public Health
: Service Act and associated regulations, many of which are not directly
| s**********8
发帖数: 25265 | 3 ur eyes like a PDA, call do a full spectrum fast
【在 l*****f 的大作中提到】
: wow, this is really long
: but i was able to skim it in 2 seconds
| l*****f
发帖数: 359 | 4 what is a PDA? Personal Dumbness Assessment?
【在 s**********8 的大作中提到】
: ur eyes like a PDA, call do a full spectrum fast
| s**********8
发帖数: 25265 | 5 photodiode array..
【在 l*****f 的大作中提到】
: what is a PDA? Personal Dumbness Assessment?
|
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