The U.S. Food and Drug Administration (FDA) has issued a final guidance for industry #132, “Administrative Applications and the Phased Review Process,” which discusses the procedures a sponsor should follow to submit an administrative new animal drug application (NADA) or administrative abbreviated new animal drug application (ANADA) and the intended time frame for reviewing these administrative applications. The guidance also discusses how animal drug sponsors may submit data during the investigational period of new animal drug development to more efficiently seek FDA approval of a new animal drug.

FDA’s Center for Veterinary Medicine (CVM) encourages sponsors to submit data for review at the most appropriate and productive times in the drug development process. Rather than submitting all data for review as part of a complete application, the submission of data supporting discrete technical sections during the investigational phase of the new animal drug is typically the most appropriate and productive. This “phased review” of data submissions has created efficiencies for CVM and the animal pharmaceutical industry. These increased efficiencies have facilitated the approval of both pioneer and generic new animal drugs. The administrative NADA or ANADA is submitted at the end of the phased review process and reflects completion of all the technical sections necessary to fulfill the requirements for the approval of the new animal drug.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and provide recommendations, unless specific regulatory or statutory requirements are cited.

Although this guidance has been finalized, you can submit comments at any time. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2002-D-0147 in the search box. To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2002-D-0147 on each page of your written comments.

Division of Dockets Management
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Food and Drug Administration
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Rockville, MD 20852