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Table of Contents
About CVM
Mission Statement
CVM Organization Chart
Vision Statement
Guiding Principles
Introduction
A Brief History of CVM
Structure/ Responsibility
CVM Annual Reports
Safeguarding Animal Hlth
Office of the Director (OD)
Mgmt & Communications
CVM & Budget
Ofc of New Animal Drug
Surveillance/Compliance
Office of Research
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CVM Update: Dr. Vaughn
Selected As ONADE Director
The Office of New Animal Drug Evaluation's (ONADE's) major
responsibility is to review information submitted by drug sponsors
who desire to obtain approval to manufacture and market animal
drugs. A new animal drug is deemed unsafe unless there is an
approved new animal drug application. Virtually all animal drugs
are "new animal drugs" within the meaning of the term
in the Federal Food, Drug, and Cosmetic Act.
ONADE determines whether or not an animal drug should be approved
for marketing. Before a new animal drug receives FDA approval,
it must be clinically tested for effectiveness and safety. If
a product is intended for use in a food-producing animal, it
must also be tested for safety to human consumers, and the edible
animal products must be free of unsafe drug residues. The sponsor
must also develop analytical methods to detect and measure drug
residues in edible animal products. It is the responsibility
of the drug sponsor (the individual or firm seeking FDA approval
of the drug product) to conduct the necessary tests.
ONADE performs the following tasks in their review of applications:
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Determines the adequacy of information submitted for proposed
use of investigational new animal drugs (INAD).
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Evaluates the safety and effectiveness of new animal drugs.
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Evaluates the safety for human consumption of drug residues
in food derived from treated animals.
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Evaluates the effect of animal drugs on the environment.
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Evaluates manufacturing methods and procedures for new
animal drug products.
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Recommends to the Center Director appropriate action on
new animal drug applications and abbreviated new animal
drug applications (for generic drugs).
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Coordinates the development and implementation of regulations
and policies pertaining to new drugs intended for animal
use.
There are two main processes involved in regulating the interstate
shipment of animal drug products. The first process,
the Investigational New Animal Drug exemption (INAD), involves
the interstate shipment of experimental drugs used for testing
in animals. This testing may require drugs be given to animals
that will later be used to produce human food products. FDA
must ensure that the food products derived from these experimental
animals will be safe for human consumption. The second process
is the NADA review. It includes the evaluation of data regarding
an animal drug's safety to the target animal and to humans who
might consume products from the treated animal; the review also
evaluates effectiveness for the purposes claimed. To be legally
marketed, a new animal drug product must be approved under an
NADA.
ONADE is divided into several different groups charged with
the evaluation of both INAD and NADA submissions. Efficacy and
safety information for the animals is evaluated by two therapeutic
use groups (food animals and non-food animals) and one group
which evaluates production drugs. Additional groups in the Office
are responsible for reviewing other aspects of submissions.
The human food safety group evaluates the safety to the public,
the user (the producer or veterinarian), analytical methods,
withdrawal times, and provides the drug tolerances so that safe
residue levels and conditions of use are provided to the public.
The manufacturing chemistry group evaluates the manufacturing
processes, quality control and environmental safety. The biometrics
group provides statistical support to ONADE and the rest of
the Center.
The various groups in ONADE review the information and any
amendments in the NADA. A determination is then made as to whether
the information provided in submissions concerning a new animal
drug shows the product will be safe and effective for its intended
use. If the information shows the drug is safe and effective,
a recommendation is provided to the Center Director that the
NADA should be approved. If the Director agrees, he/she approves
the application and a notice of approval is published in the
Federal Register.
INAD and NADA sponsors usually include university researchers,
contract researchers, private practitioners, drug manufacturers,
and/or feed or food manufacturers in their protocols. The activities
of the investigators are monitored through the bioresearch monitoring
program. The sponsors data generation processes are validated
through on-site inspections by FDA field personnel. Reports
covering laboratory practices relating to toxicology and safety
research, and the functions of clinical investigators and sponsors
are forwarded to CVM for evaluation.
A sponsor must conduct certain tests to show that a drug is
safe for the target animal, has the intended effect, and that
edible products derived from treated animals are safe for human
consumption. If animals receiving an investigational drug are
to be slaughtered for consumption, authorization to do so is
needed from the FDA. These animals must be slaughtered in a
Federally-inspected facility. The USDA, in coordination with
the FDA, provides for a USDA inspector to monitor the slaughter
of research animals intended for human consumption.
Usually drug approval process begins with the sponsor submitting
a request for an exemption to use a particular substance for
experimental purposes. CVM can grant this under an INAD. Once
an INAD exemption has been granted according to the requirement
of the FFDCA, the sponsor must do the following:
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Assure the proper and safe packaging and labeling of investigational
drugs.
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Report the names and locations of investigators to whom
drugs are shipped.
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Maintain records of all drug shipments and of all reports
received from investigators.
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Notify FDA immediately if a safety problem is observed.
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Notify FDA or USDA prior to slaughter of animals treated
with the investigational drug.
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A request for a categorical exclusion from an Environmental
Assessment.
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An important function in the INAD process for all ONADE
staff is review of submitted protocols for experimental
work conducted to provide the necessary information needed
for the approval of the NADA.
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A sponsor may submit individual completed technical sections
(such as target animal safety, effectiveness, human food
safety, freedom of information (FOI), and labeling) for
"phased review" under the INAD, or the entire
requirements for approval may be provided in one submission
as an NADA.
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An "original" NADA (the initial application for
approval of a new animal drug) should contain all of the
following information:
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A signed copy of the FDA 356V (New Animal Drug Application).
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A well-organized summary of the information in the application.
Updated Wednesday, October 30, 2002 at 3:15
PM ET - mdt
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