federal_register: 2020-07752

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2020-07752 International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #259 entitled "Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV" (VICH GL58). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is an annex to the VICH parent stability guidance, GFI #73 (VICH GL3(R)), "Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)," and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration or application submitted within the regions in climatic zones III and IV. 2020-04-14 2020 4 https://www.federalregister.gov/documents/2020/04/14/2020-07752/international-cooperation-on-harmonisation-of-technical-requirements-for-registration-of-veterinary https://www.govinfo.gov/content/pkg/FR-2020-04-14/pdf/2020-07752.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #259 entitled "Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV" (VICH GL58)....  

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