Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs

Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs This guidance document is intended to provide sponsors with an outline of the chemistry and manufacturing, clinical, and human safety requirements for the filing of the following submission types with the Veterinary Drugs Directorate (VDD): Abbreviated New Drug Submission (ANDS); Changes to ANDS - Supplemental Abbreviated New Drug Submission (SANDS) and Notifiable Change (NC). 2021-07-08 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyGuidance for industryveterinary abbreviated new drug submissionspreparation of veterinary abbreviated new drug submissionssupplemental abbreviated new drug submissionnotifiable changegeneric drugschemistry and manufacturingclinicaland human safety requirementsVeterinary Drugs Directorate Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic DrugsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/veterinary-drugs/legislation-guidelines/guidance-documents/guidance-industry-preparation-veterinary-abbreviated-new-drug-submissions-generic-drugs-health-canada-2009-1.html#a1 Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic DrugsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments-veterinaires/legislation-lignes-directrices/lignes-directrices/ligne-directrice-intention-industrie-preparation-presentations-abregees-drogues-nouvelles-veterinaires-medicaments-generiques-sante-canada-2009.html#a1

This guidance document is intended to provide sponsors with an outline of the chemistry and manufacturing, clinical, and human safety requirements for the filing of the following submission types with the Veterinary Drugs Directorate (VDD): Abbreviated New Drug Submission (ANDS); Changes to ANDS - Supplemental Abbreviated New Drug Submission (SANDS) and Notifiable Change (NC).

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