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GUIDANCE DOCUMENT

CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs August 2020

Download the Final Guidance Document
Final
Docket Number:
FDA-2008-D-0614
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The guidance explains how the Office of New Animal Drug Evaluation (ONADE) categorizes possible changes to approved new animal drugs that require reevaluation of safety and/or effectiveness data and explains which administrative vehicle — a new original new animal drug application (new NADA) or a Category II supplemental application to the original new animal drug application (Category II supplemental NADA) — a sponsor should use when applying for approval of these changes. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by ONADE.

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5630 Fishers Lane, Rm 1061
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All written comments should be identified with this document's docket number: FDA-2008-D-0614.

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