UPDATED January 20, 2016: The FDA has issued the final version of Guidance for Industry #226 Target Animal Safety Data Presentation and Statistical Analysis.
March 30, 2015
The U.S. Food and Drug Administration today issued draft guidance for industry entitled, “Target Animal Safety Data Presentation and Statistical Analysis,” which provides recommendations to animal drug sponsors on the presentation and statistical analyses of target animal safety (TAS) data submitted as part of a study report to support approval of a new animal drug.
Target animals are the species and class of animal (e.g. lactating dairy cow) the drug is intended to be used in after approval. The FDA recommendations apply to TAS data generated from both TAS studies and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry).
Guidance documents represent the FDA’s latest thinking on particular topics, policies and regulatory issues. While guidance documents are prepared primarily for the benefit of industry, they also are used by FDA staff and other stakeholders to understand the agency’s interpretation of regulations and policies.
The FDA is accepting public comments beginning on Tuesday, March 31, 2015. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2015-D-0839 in the search box.
To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2015-D-0839 on each page of your written comments.
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Notice of Availability; Draft Guidance for Industry; Target Animal Safety Data Presentation and Statistical Analysis
- Guidance for Industry #226 - Target Animal Safety Data Presentation and Statistical Analysis (PDF - 561KB)
- Regulations.gov: please note that the public comment period opens on Tuesday, March 31, 2015