federal_register: 2015-10480

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2015-10480 Administrative Applications and the Phased Review Process; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #132 entitled "Administrative Applications and the Phased Review Process." This guidance defines the "phased review process" for reviewing application-level information during the investigational period of new animal drug development, and an "administrative" new animal drug application (NADA) or abbreviated new animal drug application (ANADA), the content, the procedures a sponsor should follow to submit such an application, and the intended time frame for its review. 2015-05-06 2015 5 https://www.federalregister.gov/documents/2015/05/06/2015-10480/administrative-applications-and-the-phased-review-process-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2015-05-06/pdf/2015-10480.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 (GFI) #132 entitled "Administrative Applications and the Phased Review Process." This guidance defines the "phased review process" for reviewing...

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