CVM GFI #106 The Use of Published Literature in Support of New Animal Drug Approvals | Guideline Explorer

Description

The purpose of this document is to provide guidance to animal drug sponsors on specific areas of the approval process where the available scientific literature may be useful to support the approval of a new animal drug application (NADA), an abbreviated new animal drug application (ANADA), or a conditionally approved new animal drug application (CNADA), as well as methodologies to ensure the validity of conclusions drawn by animal drug sponsors from the scientific literature to support an approval.

Scope & Applicability

Product Classes

2

New Animal Drug

The category of products covered by this guidance.

Generic Animal Drug

Subject of ANADA submissions

Stakeholders

3

Sponsor

Entity responsible for submitting applications under section 524B

Manufacturer

Entity responsible for submitting NDINs

Information specialist

Recommended for search term/strategy development and refinement.; Recommended role for design of literature search

Regulatory Context

Attributes

10

Substantial Evidence of Effectiveness

The legal standard for proving a drug works; Legal standard required for drug approval

Bias code

1=high risk of bias, 2=low risk of bias, 3=unclear risk

Expiration date

should be based on appropriate supportive stability data

Concentration

Mass or units of activity per unit volume for fee assessment

Superiority

Objective of showing response to intervention is superior to a comparator.

Critical Quality Attribute

The degree of uncertainty can impact the critical quality attribute (CQA) risk ranking

Bioequivalence

Risk factor to be assessed during manufacturing changes

Heterogeneity

Variations in patient preferences even within the same disease state

Statistical Power

adequate statistical power and accounting for planned analyses

ALCOA

Attributable, legible, contemporaneously recorded, original, and accurate

Identified Hazards

Hazards

6

Antimicrobial Resistance

Public health threat resulting from loss of effectiveness of antimicrobial therapies; Efforts to mitigate the development of antimicrobial resistance.; Public health concern that labeling changes aim to mitigate.; development and spread of antimicrobial resistance encouraged by certain practices

Statistical bias

Difference between the parameter to be estimated and the mathematical expectation of the estimator.

Selection bias

Systematic differences between baseline characteristics of compared groups.; Reporting study specific bias such as selection bias

Reporting bias

Bias introduced when only selected outcomes are reported, including publication and citation bias.

Publication Bias

Risk reduced by including non-publicly available studies

Bias

mitigate potential unwanted bias in learning or performance estimation

Related CFR Sections (4)

21CFR514.117§ 514.117 Adequate and well-controlled studies.
(a) Purpose. The primary purpose of conducting adequate and well-controlled studies of a new animal drug is to distinguish the effect of the new animal drug from other influences, such as spontaneous change in the course of the disease, normal animal production performance, or biased observation. OnRead full regulation →
21CFR58.3§ 58.3 Definitions.
As used in this part, the following terms shall have the meanings specified:Read full regulation →
21CFR514.4§ 514.4 Substantial evidence.
(a) Definition of substantial evidence. Substantial evidence means evidence consisting of one or more adequate and well-controlled studies, such as a study in a target species, study in laboratory animals, field study, bioequivalence study, or an in vitro study, on the basis of which it could fairlyRead full regulation →
21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →

Related Warning Letters (9)

Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
2025-08-26
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Sanitation & Environmental Technology Institute dba SDWH
2024-09-11
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Samm Solutions, Inc., d.b.a. BTS Research
2023-10-31
Bioresearch Monitoring Program
Valley Biosystems
2022-08-09
Good Laboratory Practice (GLP)
Toxikon Corporation/Labcorp Bedford LLC
2022-02-22
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
University of Kentucky
2020-05-05
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Steiner Biotechnology, LLC
2020-04-07