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FDA issues draft guidances to facilitate new animal drug submissions

Agency also releases updated draft guidance for MUMS drug program.

The U.S. Food & Drug Administration announced July 14 the availability of four draft guidance documents that, if finalized, may encourage animal drug sponsors to use "innovative approaches as they prepare data submissions related to new animal drug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 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.

On July 16, 2019, FDA’s Center for Veterinary Medicine (CVM) held a public meeting -- “Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs” -- during which the public provided comments on these topics. The public was given until Sept. 16, 2019, to submit comments on the topics discussed at the recent 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at the public meeting and the questions published in the meeting notice, and those comments were considered as the draft guidance documents were developed.

FDA is now announcing the availability of four draft guidance for industry (GFI) documents:

1. Draft 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 & Cosmetic (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. CVM said it 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.

2. Draft GFI #266. “Use of Real-World Data & Real-World Evidence to Support Effectiveness of New Animal Drugs” would, if finalized, describe 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.

3. Draft GFI #267. “Biomarkers & Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs” would, if finalized, describe 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.

4. Draft GFI #268. “Adaptive & Other Innovative Designs for Effectiveness Studies of New Animal Drugs” would, if finalized, describe 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.

Revised MUMS draft guidance

In a separate announcement, FDA also released updated information to help researchers and animal drug sponsors navigate the pathway to approval for animal drugs intended for minor uses and minor species (MUMS).

FDA’s mission is to protect and promote the health of both human and animals, including animals that are considered “minor species” — animals other than those typically thought of as livestock (cattle, pigs, chickens and turkeys) or companions (dogs, cats and horses). Minor species are animals that may not be quite as common, such as sheep, goats and ferrets but also zoo animals, wildlife and insects like honeybees.

Similarly, FDA has a responsibility to facilitate approval of treatments for conditions that are relatively rare in the major species or that occur in small numbers or in limited geographic areas. Some examples of minor uses in major species include various cancers in dogs or regional occurrences of diseases, such as outbreaks of blackhead in turkey flocks in the southern U.S.

Because MUMS drugs, by definition, are for use in relatively small markets, there is less economic incentive for a drug company to invest in the research and development necessary to bring a product to market via the traditional new animal drug approval process.

According to CVM, many of those seeking approval for MUMS drugs are new to the new animal drug approval process. The new draft Guidance #61 -- “Special Considerations, Incentives & Programs to Support the Approval of New Animal Drugs for Minor Uses & for Minor Species” -- FDA released July 14 differs from previous versions in that it provides a chronological “playbook” of the new animal drug approval process for MUMS drugs and explains the various scenarios that might arise along the way.

This guidance also explains how to navigate the various components of the MUMS program so sponsors can use them to their benefit when pursuing drug approval. For sponsors of products intended for use in aquaculture, the guidance describes special considerations that apply.

Although the public may submit comments on any FDA guidance document at any time, the agency suggests that comments on the first four draft guidances be submitted within 90 days to ensure that comments are considered before FDA begins work on the final version of the guidance documents. The MUMS draft Guidance #61 is open for 120 days, starting July 15.

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 & Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs”;
  • FDA-2020-D-1401 for draft GFI 268 “Adaptive & Other Innovative Designs for Effectiveness Studies of New Animal Drugs,” and
  • FDA-1997-D-0444 for draft GFI 61 “Special Considerations, Incentives & Programs to Support the Approval of New Animal Drugs for Minor Uses & for Minor Species” (comments open until Nov. 12).

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

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

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