The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #237 entitled ``Oncology Drugs for Companion Animals.'' The guidance provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a new animal drug application (NADA) for certain oncology drugs, and provides recommendations on how to address human user safety concerns.
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Oncology Drugs for Companion Animals; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #237 entitled ``Oncology Drugs for Companion Animals.'' Th...
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81 FR 37605
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“Oncology Drugs for Companion Animals; Draft Guidance for Industry; Availability,” thefederalregister.org (June 10, 2016), https://thefederalregister.org/documents/2016-13789/oncology-drugs-for-companion-animals-draft-guidance-for-industry-availability.