federal_register: 2023-05465

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2023-05465 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Rule The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during October, November, and December 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations. 2023-03-20 2023 3 https://www.federalregister.gov/documents/2023/03/20/2023-05465/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsor https://www.govinfo.gov/content/pkg/FR-2023-03-20/pdf/2023-05465.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new...

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