RECOMMENDED NON-TEXTBOOK READINGS FOR PREPARATION OF THE
AMERICAN COLLEGE OF VETERINARY CLINICAL PHARMACOLOGY CERTIFYING
EXAMINATION*
I. Regulatory related topics
As of 1/2014, these guidelines can be found at:
http://www.fda.gov/animalveterinary/ for links to FDACVM Guidance documents (see links
under "Animal and Veterinary Topics";
http://www.fda.gov/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/defa
ult.htm and use the search tool (eg, “Guidelines”; if you know the Guidance number, the
specific guidance also can be found at:
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/u
cm042450.htm). Although links are provided below, these often change and it is the
responsibility of the examinee to search and find the documents.
An emphasis would include:
A. Guidelines for Industry:

Adverse event reporting:
VICH GL24 - Management of Adverse Event Reports (AER's)
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidance
forIndustry/UCM052657.pdf (WHEN FINAL; Not Final as of 1/31/2014

Antimicrobial Resistance
GFI # 152- Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their
Microbiological Effects on Bacteria of Human Health Concern
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM052519.pdf
GFI # 209 - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing
Animals
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM216936.pdf
Additional non-guidance document: FDA’s Strategy on Antimicrobial Resistance –
Questions and Answers
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIn
dustry/ucm216939.htm

Chemistry Manufacturing and Controls (CMC)
GFI #145 - Bioanalytical Method Validation
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid
ances/UCM070107.pdf

Generics
CVM GFI #35 Bioequivalence Guidance
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidance
forIndustry/UCM052363.pdf
GFI #171 – Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble
Powder Oral Dosage Form Products and Type A Medicated Articles.
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidance
forIndustry/UCM052493.pdf

Human Food Safety
CVM GFI #3 General Principles for Evaluating the Safety of Compounds Used in Food Producing
Animals
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM052180.pdf
GFI # 152 – Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to
Their Microbiological Effects on Bacteria f Human Health Concern.
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM052519.pdf
VICH GL36 - Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
General Approach to Establish a Microbiological ADI
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM124674.pdf
VICH GL48 - Marker Residue Depletion Studies to Establish Product Withdrawal
Periods
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM207941.pdf

MUMS:
GFI # 61 – FDA Approval of New Animal Drugs for Minor Uses and for Minor Species
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM052375.pdf

New Animal Drug Applications
GFI #132: The Administrative New Animal Drug Application Process
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM052532.pdf

Target Animal: Effectiveness
CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety
Trials (same as in safety)
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidance
forIndustry/UCM052372.pdf
CVM GFI #3 General Principles for Evaluating the Safety of Compounds Used in Food Producing
Animals
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidance
forIndustry/UCM052180.pdf

Target Animal : Safety
CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety
Trials http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforceme
nt/GuidanceforIndustry/UCM052372.pdf
VICH GL43 - Target Animal Safety for Veterinary Pharmaceutical Products
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM052464.pdf

VICH:
VICH GL 9: Good Clinical Practice
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM052417.pdf
VICH GL 6: Environmental Impact assessments (EIA’s) for veterinary Medicinal
Products - Phase I
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM052424.pdf
VICH GL 38 – Environmental Impact Assessments (EIA’s_ for Veterinary medicinal
Products (VMP’s ) – Phase II
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Gui
danceforIndustry/UCM052500.pdf
B. In addition, these guidance may be relevant

Guidance for Industry: Choice of Control Groups and Related Issues in Clinical Trials
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guid
ances/UCM073139.pdf

Guidance for Industry: Statistical Principles for Clinical Trials
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidanc
es/ucm073137.pdf
C. Compliance Policy Guidelines
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CPG Sec. 608.400 Compounding of Drugs for Use in Animals
CPG Sec 615.115 Extra-Label Use of Medicated Feeds for Minor Species
CPG Sec. 625.200 Availability of Bulk Chemicals for Animal Drug Use
CPG Sec. 645.100 Biological Drugs for Animal Use
CPG Sec. 650.100 Animal Drugs for Euthanasia
CPG Sec. 655.100 Devices for Use in Animals
D. The Animal Medicinal Drug Use Clarification Act (AMDUCA; CFR Title 21)
http://www.fda.gov/animalveterinary/guidancecomplianceenforcement/actsrulesregulatio
ns/ucm085377.htm
Extralabel Drug Use, including Compounding
http://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm380135.htm
Drugs Prohibited for Use in Food animals: http://www.gpo.gov/fdsys/pkg/CFR-2013title21-vol6/xml/CFR-2013-title21-vol6-sec530-41.xml