FDA: The New Animal Drug Approval Process

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Minor Technical Sections• Labeling• All Other Information• (FOI)

Administrative NADA• Administrative New Animal Drug Application(NADA)• Administrative application submitted after alltechnical sections are completed• Completion of Administrative NADA = FDAapproved product• Non-administrative NADA

Page 1 and 2: FDA: The New Animal DrugApproval Pr
Page 3 and 4: What does FDA regulate?CFSANCVMCDER
Page 5 and 6: What is a Drug?• Under the Act, t
Page 7 and 8: What drugs can be legallymarketed?
Page 9 and 10: ADUFA Fees• Animal Drug User Fees
Page 11 and 12: INAD• Open the INAD- Provide as m
Page 13 and 14: Presubmission Conference• After s
Page 15: Major Technical Sections• Safety-
Page 19: Contact InformationLynne Boxer, DVM

FDA: The New Animal Drug Approval Process

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