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  1. CVM Updates

FDA Issues Draft Guidances to Help Facilitate the Development of New Animal Drug Submissions

July 14, 2020

Today the U.S. Food and Drug Administration (FDA) is announcing the availability of four draft guidance documents that, if finalized, will help encourage animal drug sponsors to use innovative approaches as they prepare data submissions related to new animal drug products for agency evaluation and review, as part of the FDA’s new animal drug approval process. The recommendations in these guidance documents align with those already issued by FDA’s other medical product centers. 

Section 305 of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 directed the FDA to hold a public meeting for interested parties to discuss innovative animal drug investigation designs and to issue guidance to assist drug sponsors in incorporating complex adaptive and other novel investigation designs, data from foreign countries, real-world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs. On July 16, 2019, the FDA’s Center for Veterinary Medicine (CVM) held a public meeting entitled “Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs” during which the public provided comments on these topics. The public was given until September 16, 2019, to submit public comments on the topics discussed at the public meeting and the questions published in the meeting notice. 

CVM received numerous comments on the topics discussed at the public meeting and the questions published in the meeting notice and those comments were considered as the draft guidance documents were developed. 

The FDA is announcing the availability of four draft guidances for industry.  Draft guidance for industry (GFI) #265, “Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs,” would, if finalized, describe the agency’s current thinking on how to assist sponsors in incorporating data from foreign countries to support the demonstration of effectiveness of new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and how to obtain feedback from CVM about the use of such data in investigations and study protocols for new animals drugs. The FDA’s CVM is committed to supporting data that may be recognized globally in order to enhance animal drug development, facilitate the use of foreign data, and minimize the need to conduct duplicative studies.   

Draft guidance for industry (GFI) #266, “Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs,” would, if finalized, describe the FDA’s current thinking on how to assist sponsors in incorporating real-world data and real-world evidence (including ongoing surveillance activities, observational studies, and registry data) into proposed clinical investigation protocols and applications for new animal drugs under the FD&C Act. If finalized, the draft guidance will explain how CVM intends to evaluate real-world data and real-world evidence in submissions to demonstrate effectiveness of new animal drugs and how to obtain feedback from CVM on technical issues related to the use of such data before the submission of an application. 

Draft guidance for industry (GFI) #267, “Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs,” would, if finalized, describe the FDA’s current thinking on how CVM intends to evaluate biomarkers, including surrogate endpoints, to determine whether they may be used to support the effectiveness of new animal drugs under the FD&C Act and how to obtain feedback from CVM on technical issues related to the use of biomarkers before submission of an application. 

Draft guidance for industry (GFI) #268, “Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs,” would, if finalized, describe the FDA’s current thinking on how sponsors could use complex adaptive and other novel investigation designs to support the effectiveness of new animal drugs  and how to obtain feedback from CVM with respect to incorporating adaptive design features into proposed investigation and study protocols for new animal drugs. 

Although the public may submit comments on any FDA guidance document at any time, we suggest you submit comment(s) on the draft guidances within 90 days to ensure that the FDA considers your comment(s) before it begins work on the final version of the guidance documents. To submit comments electronically on the guidance documents, visit www.regulations.gov and type the following docket numbers into the search box: 

  • FDA-2020-D-1396 for draft GFI #265 “Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs”;  
  • FDA-2020-D-1400 for draft GFI #266 “Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs”;   
  • FDA-2020-D-1402 for draft GFI #267 “Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs”; and 
  • FDA-2020-D-1401 for draft GFI #268 “Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs.”   

The public may also submit comments by mail using the address below and should include the relevant docket number on each page of your written nomination: 

Dockets Management Staff 
HFA-305 
Food and Drug Administration 
5630 Fishers Lane, Room 1061 
Rockville, MD 20852 

For more information: 

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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