Series of four guidelines entitled "Animal Drug Manufacturing Guidelines"

Revised --

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE

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Table of Contents

Top of Document

• PILOT BATCH MANUFACTURE
  • A. INTRODUCTION
  • B. RECOMMENDATIONS FOR NADA's AND ANADA's
  • C. RECOMMENDATIONS FOR SUPPLEMENTAL NADA's AND ANADA's

• TENTATIVE EXPIRATION DATES
  • A. INTRODUCTION
  • B. DEFINITIONS
  • C. RECOMMENDATIONS FOR ESTABLISHING A TENTATIVE EXPIRATION DATE FOR ANADA's
    

• MANUFACTURING SITES
  • A. INTRODUCTION
  • B. DEFINITIONS
  • C. RECOMMENDATIONS FOR THE SUBMISSION OF APPROPRIATE DATA AND INFORMATION

• NEW ANIMAL DRUG SUBSTANCE SOURCES
  • A. INTRODUCTION
  • B. DEFINITIONS
  • C. RECOMMENDATIONS FOR THE SUBMISSION OF APPROPRIATE DATA AND INFORMATION

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