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What is FDA

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What is FDA
The Food and Drug Administration (FDA) touches the lives of
virtually every American, every day. It’s FDA’s job to see that
medicines and medical devices are safe and effective
FDA is a federal science-based law enforcement agency
mandated to protect public health. The agency has
approximately 9.000 employees, most of whom are scientists,
inspectors, medical doctors, and other professionals. FDA’s
budged is $ 1.2 billion, or about $ 4 a year peer taxpayer

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The mission
FDA’s mission is to ensure the safety and
effectiveness of the products under its
jurisdiction. These products are worth about a
trillion dollars a year and make up 22% of all
consumer expenditures.

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The mission
FDA accomplishes its mission by establishing and enforcing high
product standards and other regulatory requirements
authorized or mandated by the Federal Food, Drug and Cosmetic
Act (FD&C Act), its amendments, and other public health laws.
The purpose of this legislative framework is to make sure that:

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The mission
•human and veterinary drugs are safe and effective
•there is reasonable assurance of the safety and
effectiveness of devices intended for human use.
•(cosmetics are safe and properly labeled)
•(public health and safety are protected from
electronic product radiation)
•(foods are safe, wholesome, sanitary, and
properly labeled)

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A brief history
1862 Due to the growing necessity for safe food and
drug products. President Abraham Lincoln appointed
chemist Charles M. Wetherill to head the chemical
division in the newly created Department of
Agriculture.
1883 Chief Chemist Harvey W. Wiley petitioned for a
federal law prohibiting the adulteration and
misbranding of foods and drugs.

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A brief history
1906 Upton Sinclair’s description of the lack of
hygiene at the Chicago stockyards in his muckraking
novel, The Jungel, prompted prohibiting interstate
commerce in misbranded and adulterated foods,
drinks, and drugs.
1938 Following the death of 107 persons, mostly
children, who took a poisonous Elixir of Sulfanilamide,
Congress greatly strengthened the public health
protection by passing the Federal Food, Drug and
Cosmetic Act

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A brief history
1962 Dr. Frances Kelsey, an FDA medical officer,
prevented a major tragedy by refusing to allow the
marketing of thalidomide, a s sleeping pill that lacked
sufficient evidence of safety. Responding to thousand
of birth defects that the drug was causing in Europe
and South America, Congress passed the Kefauver-
Harris Amendments requiring evidence of drug
effectiveness as well as greater safety.

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A brief history
1976 Congress passed the Medical Device
Amendments that extended the requirements of
safety, effectiveness, and quality control procedures
to medical devices and diagnostic products. This
passage was preceded by a U.S. Senate report that
faulty medical devices had caused in 10 years
10.000 injuries, 731 of which were fatal.

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A brief history
Today FDA implementing the FDA Modernization
ACT of 1997, which was passed by Congress after
three years of FDA scrutiny and covers all of the
agency’s activities and programs. With an 80%
favorable rating in public polls, the agency is
cooperating with its stakeholders in the U.S. and
aboard to continue protecting consumers and the
public health in the new era of unprecedented
technological and scientific advances.

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Food, Drug and Cosmetic Act
(FD&C)
This Act, passed in 1938, remains FDA’s main legal basis. It
greatly enlarged the agency’s mission and authority by:
• requiring that new drugs be shown to be safe before
marketing.
• extending FDA’s control to cosmetics and therapeutic
devices.
• authorizing factory inspections and standards of identity for
food staples.
• eliminating a requirement to prove intent to defraud in drug
misbranding cases.
• adding court injunctions to the previous penalties of seizures
and prosecutions.

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FDA Modernization Act of 1997
(FDAMA)
In FDAMA, Congress recognized that the protection of
public health is a responsibility shared by the entire health
care community. The law directs the agency to carry out its
mission in consultations and cooperation with all FDA
stakeholders, including consumer and patient groups, the
regulated industry, health care professionals, and FDA’s
regulatory counterparts abroad.

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Labeling
In addition to setting product standards, FDA regulates the
labeling of products under its jurisdiction. This information,
which must be rigorously truthful, well documented, and
not misleading, plays a major role in protecting consumers
and the public health. The FDA-regulated labeling of drugs
and medical devices gives pre-scribers and patients reliable
guidance about the safety and effectiveness of health care
products.

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How is FDA organized?
FDA is organized into eight offices and program Centers:
Commissioner’s office
FDA is headed by the Commissioner of Food and Drugs who
is appointed by the President of the United States,
confirmed by the U.S. Senate, and serves at the President’s
discretion. The Office of the Commissioner oversees all of
the Agency’s activities.

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How is FDA organized?
Specialized program Centers
FDA is organized into several specialized program Centers
that are responsible for protecting the public’s health.
• Office of Regulatory Affairs
• Center for Food Safety and Applied Nutrition
• Center for Drug Evaluation and Research
• Center for Biologics Evaluation and Research
• Center for Veterinary Medicine
• National Center for Toxicological Research

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What is CDER’s mission?
CDER – Center for Drug Development and Research –
makes sure that safe and effective prescription, non-
prescription, and generic drugs are available to American
People as quickly as possible.
CDER fulfills this mission by overseeing the research ,
development, manufacture, and marketing of drugs.
It reviews clinical trial evidence of the safety and
electiveness of new drugs before approving them for
marketing; monitors their performance for unexpected health
risks; and ensures that drug labeling, drug information for
patients, and drug promotion are truthful, helpful, and not
misleading.

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CDER’s Drug development
Drug development is a highly complicated, lengthy process
that starts with the testing of the potential medication in vitro
in a laboratory and in animals. When the firm is ready to test
the compound in humans, CDER reviews the manufacturer’s
design (IND) for clinical studies to make sure they will
answer important questions about the drug’s safety and
effectiveness. FDA monitors the subsequent trials to protect
the rights of the participants and the integrity of the resulting
data. Following the completion of the required clinical trials
that test the product’s safety, effectiveness, and dosage,
CDER reviews the results and, if the product’s benefits
outweigh its risks, it may approve the drug for marketing
(NDA).

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Good Manufacturing Practices
To make sure that drugs are manufactured to the
same high standards that are required for their
approval, FDA has developed a set of regulations
called the current Good Manufacturing Practices
(cGMPs). The law requires periodic inspections of all
drug firms for compliance with GMPs.

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Drug safety
Every drug that affects the body has some side effects.
Since FDA approves only those drugs whose benefits
outweigh their risks, the side effects of properly used
drugs usually are not serious. To further mitigate the
potential risks, FDA includes emphatic warnings about
possible adverse events in the product labeling and the
drug information for patients that is routinely included
with the packaged product.

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Adverse event reporting
FDA maintains several reporting systems that alert the
agency to side effects that were not detected during clinical
trials, but emerged when the product became widely used.
One of these programs is CDER’s MedWatch, which
encourages particularly health professionals to report
serious adverse events for the agency’s analysis. If
necessary, FDA can take regulatory actions to protect
patients that include restrictions on the product’s use or its
withdrawal from the market. About 1%-3% of products
approved each year have to be removed later because of
rare, but serious side effects.

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Prescription Drug User Fee Act
(PDUFA)
In the Prescription Drug User Fee Act of 1992
(PDUFA) the U.S. Congress, pharmaceutical industry,
and FDA agreed on specific review goals for certain
drugs and biologics, to be achieved with the help of
user fees paid to FDA by the product’s manufacturers.
The program, which was re-authorized for another 5
years in 1997, has been instrumental in reducing
FDA’s median drug review times by more than one-
half.

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Prescription Drug User Fee Act
(PDUFA)
Today, typical drug applications are processed by
FDA in one year or less; priority applications for
breakthrough medications are usually approved in six
months.
PDUFA user fees, however, do not cover FDA’s
expenses connected with generic and non-
prescription drugs, plant inspections, post market
surveillance, and monitoring of drug advertisements.

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Accelerated Approval
Many of the drugs currently used to treat life-
threatening conditions, such as cancer, were
approved through an accelerated FDA review
process.
In accelerated approval, FDA approves the drug on
the condition that the applicant studies and reports
findings of the clinical benefit of the drug. FDA
continues to review new information and data about
these drugs as the data becomes available. If the
findings are negative, the appropriate actions are
taken.

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What is CBER’s mission?
The mission of CBER – FDA’s Center for Biologics
Evaluation and Research – is to ensure the safety
and effectiveness of biological products for the
prevention and treatment of human diseases.

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What is a biologic, or biological
product?
Biological products are made from living organisms —
they can be derived from human, plant, animal, or micro
organism sources.
Examples of biological products include blood, blood
components and derivatives, tissues, allergenic
extracts, vaccines, drugs derived from biotechnology,
and certain diagnostic products. Other examples
include somatic cell therapy, gene therapy or the
transplantation of animal organs or tissues into
humans.

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Regulating biologics
CBER’s activities include:
• monitoring the pre-clinical and clinical testing of
new biological products, and evaluating their
safety and effectiveness before marketing.
• licensing biological products and manufacturing
establishments, including blood banks.
• research on AIDS medications, diagnostic tests,
and vaccines.
• compliance monitoring, lot releasing, and post
market surveillance.

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Approving a biologic
CBER staff reviews clinical research and laboratory
testing data to determine if the biologic is safe and
effective for its intended use.
In order for a biological product to be approved for
marketing in the U.S., an applicant must submit a
Biologics License Application (BLA). The BLA must
include information on the following:

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Approving a biologic
• animal studies and human clinical trials performed
• how the biologic is manufactured, processed, and
packaged, including information on the quality
control methods used during its manufacture
• labeling that will be used with the product

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Approving a biologic
Once a biological product is approved, its identity and
manufacturing process cannot change without prior
FDA approval.

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Blood supply
Assuring the safety of,
and the public
confidence in, the
nation’s blood supply is
one of CBER’s main
priorities. There are five
overlapping safeguards
in place to help protect
the safety of blood.
• quarantine of untested blood
• donor screening
• donor deferral registries
• blood testing
• investigations of problems

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Blood supply – Devices -
It’s important to note that some of the products
regulated by CBER are devices. These include
products used in the collection and processing of
blood products, such as blood bags, centrifuges, and
test kits that are used to screen donated blood for
infections diseases such as HIV and Hepatitis.

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What is CDRH’s mission
FDA’s Center for Devices and Radiological Health
(CDRH) is responsible for ensuring the safety and
effectiveness of an medical devices and protecting
consumers against harmful man-made radiation from
medical, occupational, and consumer products.

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What is a medical device?
The FD&C Act defines a medical device as, “any
health care product that does not achieve its principle
intended purposes by chemical action or by being
metabolized.”
Under this definition, a “device” can be as simple as a
tongue depressor or a thermometer, or as complex as
a kidney dialysis machine.
Medical devices are classified and regulated according
to their degree of risk to the public.

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Regulatory classes for devices
Because each device is different, FDA establishes
three different regulatory classes to ensure that each
device is subject to regulations that are appropriate.

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Regulatory classes
• Class I – General Controls
Class I devices are subject to a set of general
regulations that apply to all devices.General controls
include the registration of manufactures, general
record keeping requirements, and compliance with
Good Manufacturing Practice regulations.

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Regulatory classes
• Class II – Special Controls
Class II devices are those for which general regulations
are not enough to guarantee the safety of the device. A
Class II device may be subject to specific regulations in
order to provide assurance of the product’s safety.
These specific regulations may include requirements for
meeting performance standards recognized by FDA,
post-market surveillance, patient registries, and other
appropriate requirements.

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Regulatory classes
• Class III – Pre Market Approval
A device is considered Class III if the device is life
supporting or life-sustaining, or is important in preventing
impairment of human health. For a Class III device,
general controls may be insufficient to provide reasonable
assurance of its safety and effectiveness. These products
require FDA pre-approval before they are marketed. Under
Class III regulations, devices such as heart valves, breast
implants, and cranial electrotherapy stimulators must be
reviewed for safety and effectiveness prior to marketing.

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Obtaining FDA Approval
A manufacturer of a Class III device files a Pre-Market
Approval Application (PMA) to obtain FDA approval to
market the product. Like the submission that is filed for
the approval of a new drug, a PMA contains clinical and
laboratory testing data to demonstrate the safety and
effectiveness of the device.
A pre-market notification, also known as a 510(k), is an
application submitted to FDA to demonstrate that a
medical device is substantially equivalent to (i.e.,
meaning it is as safe and effective as) a legally
marketed device that does not require pre-market
approval.

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GMPs
FDA further assures the safety and effectiveness of
medical devices by regulating their manufacture. As
with drugs, FDA has established Good
Manufacturing Practices for medical devices. FDA
regularly inspects manufacturers to assure they
comply with these regulations.

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Continuous analysis
FDA’s work does not end when a medical device
has been approved. FDA continuously analyzes
reports to ensure that products are safe and to
watch for dangerous events related to the use of
medical devices. CDRH also monitors certain
electronic products in order to protect the public from
unnecessary exposure to radiation. Products that
are monitored by FDA include televisions,
microwave ovens, x-ray machines, and even the
lasers used in laser light shows. FDA administers
the law by setting and enforcing standards to limit
unnecessary radiation emissions.

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Top 5 Tips for FDA InspectionTop 5 Tips for FDA Inspection