Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #261 entitled "Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs." This draft guidance is intended for persons interested in pursuing conditional approval of new animal drugs for certain major uses in major species. Eligibility for conditional approval has been expanded beyond minor uses in major species and minor species to include certain major uses. The Center for Veterinary Medicine (CVM) refers to the process for conditionally approving new animal drugs that are not minor use and minor species (MUMS) drugs as "expanded conditional approval." The purpose of expanded conditional approval is to incentivize development of new animal drugs for serious or life- threatening conditions or unmet animal or human health needs under circumstances where a demonstration of effectiveness would require a complex or particularly difficult study or studies. This draft guidance defines certain terms, clarifies the eligibility criteria for expanded conditional approval, and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2019-D-3361] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #261 entitled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.” This draft guidance is intended for persons interested in pursuing conditional approval of new animal drugs for certain major uses in major species. Eligibility for conditional approval has been expanded beyond minor uses in major species and minor species to include certain major uses. The Center for Veterinary Medicine (CVM) refers to the process for conditionally approving new animal drugs that are not minor use and minor species (MUMS) drugs as “expanded conditional approval.” The purpose of expanded conditional approval is to incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs under circumstances where a demonstration of effectiveness would require a complex or particularly difficult study or studies. This draft guidance defines certain terms, clarifies the eligibility criteria for expanded conditional approval, and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility. DATES: Submit either electronic or written comments on the draft guida…
Other Federal Register documents from the same docket.
Citation: 84 FR 51594
