federal_register: E9-27926

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-27926 Guidance for Industry on Changes to Approved New Animal Drug Applications-New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry <greek-i>191 entitled "Changes to Approved NADAs--New NADAs vs. Category II Supplemental NADAs." 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 goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by FDA's Center for Veterinary Medicine (CVM). 2009-11-20 2009 11 https://www.federalregister.gov/documents/2009/11/20/E9-27926/guidance-for-industry-on-changes-to-approved-new-animal-drug-applications-new-animal-drug https://www.govinfo.gov/content/pkg/FR-2009-11-20/pdf/E9-27926.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry <greek-i>191 entitled "Changes to Approved NADAs--New NADAs vs. Category II Supplemental NADAs." This guidance is intended to assist sponsors who wish to...

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