Animal & Veterinary

Newly Added Guidances

Guidance Documents will be retained in this section of the page for a period of three months. The most recently added appears first and they are in the order of the date they were issued.

Newly Released Guidance Documents

TitleIssued Date
CVM GFI #236 Regulation of Mosquito-Related Products (PDF - 109KB) 01/19/17
CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals (PDF - 200KB) 01/19/17
VICH GL56 - CVM GFI #243 Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods (PDF - 214KB) 01/05/17
CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products (PDF - 111KB) 01/04/17
CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section Of Animal Drug Applications (PDF - 614KB) 12/20/16
VICH GL52 - Bioequivalence: Blood Level Bioequivalence Study (PDF - 283KB) 12/16/16
Guidance for Industry: FDA's Voluntary Qualified Importer Program 06/03/15
Draft Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition) - Revised 12/12/12
CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions (PDF - 288KB) 11/02/16
CVM GFI #241 - Small Entity Compliance Guide - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PDF - 238KB) 11/01/16
Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA

Page Last Updated: 01/18/2017
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