CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission
This guidance document was prepared to enable sponsors to submit “quality” data submissions, which will allow for a more efficient review by CVM. The scope of this document is limited to submissions to the Division of Therapeutic Drugs for Non-Food Animals (HFV-110).
A complete New Animal Drug Application (NADA) must be composed of all the sections identified in 21 CFR §514.1 and as stated on the Form FDA 356V. In order to facilitate the approval of NADAs, CVM now accepts major data submissions for individual sections of an NADA (technical sections) under the Investigational New Animal Drug (INAD) file. To the extent possible, CVM reviews each technical section independently. When CVM finds that all the sections are complete the sponsor may file an “administrative NADA”. This guidance document will focus exclusively on the effectiveness and the target animal safety technical sections reviewed by the Division of Therapeutic Drugs for Non-Food Animals.
In CVM’s efforts to find ways of improving its efficiency, it was discovered that reviewers often found it difficult to locate specific elements within a technical section and determine if all necessary elements of the technical section were present in the submission. This document addresses that problem and is intended to provide guidance on the suggested content and format of technical section submissions. Adherence to this guidance should assist CVM reviewers in locating and reviewing this information. The information contained in this guidance applies whether effectiveness and target animal safety data are submitted as individual technical sections under an INAD or collectively as part of a complete NADA. This document also provides guidance on the content and format of a final study report, which is a fundamental component of these technical sections.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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 comments should be identified with the title of the guidance.