Page 125 - Veterinary Toxicology, Basic and Clinical Principles, 3rd Edition

92 SECTION | I General

VetBooks.ir to determine the appropriate classification of these pro- New Animal Drug Approval
ducts. The FFDCA definitions (in part) for these terms
As part of the preapproval process for new animal drugs,
are provided here, but the FFDCA should be consulted
for complete definitions. a drug sponsor must provide evidence that the drug is
safe for the target animal and the environment, has the
Under section 201(g) of the FFDCA, the term “drug”
intended effect, can be manufactured adequately to pre-
means articles intended for use in the diagnosis, cure, mit-
serve the product’s identity, strength, quality, and purity,
igation, treatment, or prevention of disease in man or
and for drugs approved for use in food-producing animals,
other animals, and articles (other than food) intended to
that the edible products derived from treated animals are
affect the structure or any function of the body of man or
safe for human consumption. For the purposes of this
other animals, and any component of such articles. Under
chapter, the drug “sponsor” owns the NADA and is the
section 201(v) of the FFDCA, the term “new animal
entity responsible for collecting all of the information
drug” is defined, in part, as any drug intended for use in
about a new animal drug and submitting it to the CVM
animals other than man, including any drug intended for
for review, and is also responsible for continued monitor-
use in animal feed, but not including the animal feed, the
ing of the drug’s safety and effectiveness after approval.
composition of which is such that the drug is not gener-
Requirements for NADAs are codified in 21 CFR Part
ally recognized as safe and effective for the use under the
514. Sponsors systematically address each of the required
conditions prescribed, recommended, or suggested in the
components by completing seven elements (commonly
labeling of the drug. As mandated by the FFDCA, a new
referred to as technical sections). The seven technical
animal drug may not be sold in interstate commerce
sections are: Chemistry, Manufacturing, and Controls
unless it is the subject of an approved new animal drug
(CMC); Effectiveness, Target Animal Safety (TAS);
application (NADA), abbreviated NADA (ANADA,
Human Food Safety (HFS); Environmental Safety; All
which is a generic new animal drug), conditionally
Other Information; and Labeling. The FDA has published
approved new animal drug application (CNADA), or list-
regulations and many guidance documents describing the
ing on the Index of Legally Marketed Unapproved New
approval requirements and types of studies that may be
Animal Drugs for Minor Species. Conditional approval
necessary to obtain approval to market animal drug pro-
and indexing are additional ways that drugs intended for
ducts. An explanation of all steps in the process required
minor uses or minor species can be legally marketed. See
for FDA approval is beyond the scope of this chapter;
the CVM website for a description of these and other pro-
however, a brief summary of the TAS and HFS evaluation
visions made for minor use and minor species products
process for new animal drugs is provided below. A com-
(FDA/CVM, 2017a).
prehensive description of the process is also provided on
Under section 201(h) of the FFDCA, the term
the CVM website (FDA/CVM, 2017b).
“device” means an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other
similar or related article, including any component, part,
or accessory, which is intended for use in the diagnosis of Target Animal Safety Evaluation
disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or other ani- General Considerations
mals, or intended to affect the structure or any function of The drug sponsor must show that the drug is safe to the
the body of man or other animals, and which does not target animal species when it is used according to the
achieve its primary intended purposes through chemical label. The target animal species is the specific animal spe-
action within or on the body of man or other animals and cies in which the drug will be approved for use. The TAS
which is not dependent upon being metabolized for the information needed for approval of a particular drug
achievement of its primary intended purposes. A few depends on the type of drug, species and class of animal,
examples of devices commonly used in animals include route of administration, indication, dose and frequency of
suture material, certain types of bandage materials, intra- administration, available scientific knowledge about the
venous catheters, anesthetic machines as well as radio- drug, and potentially other factors. The principles of TAS
logic imaging equipment. evaluation are outlined in the FDA-CVM Guidance for
Under section 201(f) of the FFDCA, the term “food” Industry (GFI): TAS for Veterinary Pharmaceutical
means articles used for food or drink for man or other Products (FDA/CVM, 2009a). This document was
animals, chewing gum, and articles used for components developed and implemented as part of the International
of any such article. Also, 21 CFR y507.3 defines “ani- Cooperation on Harmonization of Technical Requirements
mal food” as food for animals other than man and for Registration of Veterinary Medicinal Products (VICH),
includes pet food, animal feed, and raw materials and a program aimed at harmonizing technical requirements
ingredients. for veterinary product registration among its member