Animal & Veterinary
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New Animal Drug Application
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CVM GFI #61 FDA Approval of New Animal Drugs for MUMS (PDF - 432KB)CVM GFI #82 Development of Supplemental Applications for Approved New Animal Drugs (PDF - 238KB)CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (PDF - 162KB)CVM GFI #106 Published Literature in Support of New Animal Drug Approval (PDF - 41KB)CVM GFI #132 The Administrative New Animal Drug Application Process (PDF - 51KB)CVM GFI #153 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB)CVM GFI #191 New NADAs vs. Category II Supplemental NADAs (PDF - 161KB)CVM GFI #213 - New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (PDF - 179KB)
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