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GUIDANCE DOCUMENT

CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs May 2015

Final

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

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0614.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
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Rockville, MD 20855
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(240) 402-7002