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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 - 685KB)
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 - 220KB)
CVM GFI #106 Published Literature in Support of New Animal Drug Approval (PDF - 16KB)
CVM GFI #121 Expedited Review for NADA for Human Pathogen Reduction Claims (PDF - 13KB)
CVM GFI #132 The Administrative New Animal Drug Application Process (PDF - 97KB)
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)

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