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U.S. Department of Health and Human Services

Advisory Committees

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Background for Today's Discussion

Steven D. Vaughn, DVM

Director
Office of New Animal Drug Evaluation

Center for Veterinary Medicine
U.S. Food & Drug Administration
Rockville, MD 20855 

Background for Today's VMAC Discussion - slide 1

Slide 2

Guidance for Industry #152

  • Evaluating the safety of Antimicrobial New Animal Drugs with
    Regard to Their Microbiological Effects on Bacteria of Human
    Health Conern
  • October 23, 2003

 

Background for Today's Discussion - slide 2

Slide 3

Qualitative Risk Assessment

  • Release assessment
    - H, M, L
  • Exposure assessment
    - H, M, L
  • Consequence assessment
    - Critical important, Highly important, Important
 Background for Today's Discussion - slide 3

Slide 4

Assessment outcomes Integrated into a RISK ESTIMATION

  • HIGH
  • MEDIUM
  • LOW
Background for Today's Discussion - slide 4
Slide 5   
Approval ConditionsCategory 1
(High)
 
Category 2
(Medium)
 
Category 3
(Low)
 
Marketing Status Rx Rx/VFD Rx/VFD/OTC 
Extra-Label Use (ELU) ELU restrictions Restricted in some
cases 
ELU permitted 
Extent of use Low Low, medium Low, medium, high 
Post-approval Monitoring Yes Yes In certain cases 
Advisory Committee Review Yes In certain cases No 
 
Background to Today's Discussion - slide 5