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FDA opens first FY2025 grant funding application period for animal drugs for minus uses and minor species

FDA opens first FY2025 grant funding application period for animal drugs for minus uses and minor species
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Iowa state university of sciencePhibro animal healthDrug administrationMinor species animal healthMinor use species development of drugsIowa state universityMethod validationQuantify tulathromycin residuesCaprine liverOxytetracycline dihydrate administeredMinor useMinor species animal health actFunding opportunityAnnouncement numberMinor use species developmentMinor species

Guidance to assist sponsors of animal drugs for minor uses and minor species

Information to help researchers and sponsors navigate pathway to approval.

Minor species animal healthDrug administrationNew animal drugsMinor usesMinor speciesAquaculture species groupingMinor useMinor species animal health actLegally marketed unapproved new animal drugs

CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species

This guidance assists those interested in pursuing FDA approval of new animal drugs intended for use in minor species or for minor uses in major species. It outlines the basic requirements and special considerations, as well as available incentives to encourage development of these drugs.

Drug administrationMinor species animal healthGuidance issuing officeDocket numberMinor useMinor species animal health act

Jaguar Health Receives Complete Letter from FDA for Last of Four Major Technical Sections for the Company s Application for Conditional Approval of Canalevia (Crofelemer) for Chemotherapy-Induced Diarrhea (CID) in Dogs

Jaguar Health Receives Complete Letter from FDA for Last of Four Major Technical Sections for the Company s Application for Conditional Approval of Canalevia (Crofelemer) for Chemotherapy-Induced Diarrhea (CID) in Dogs
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United statesMichael guyLisa contePeter hodgeExchange commissionNapo pharmaceuticalsJaguar health incMinor species animal healthNapo pharmaceuticals incJaguar healthVeterinary medicineTarget animal safetyMinor speciesMinor useMinor species animal health actNew animal drug application