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GUIDANCE DOCUMENT

CVM GFI #132 Administrative Applications and the Phased Review Process May 2018

Download the Final Guidance Document
Final
Docket Number:
FDA-2002-D-0147
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance defines:

  1. the “phased review process” for reviewing application-level information during the investigational period of new animal drug development, and
  2. 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.

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All written comments should be identified with this document's docket number: FDA-2002-D-0147.

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