federal_register: E9-29419

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-29419 Electronic Margin of Safety and NonClinical Toxicology Study Data Submission; Notice of Pilot Project Notice The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) is seeking sponsors interested in participating in a pilot project to test the electronic submission of margin of safety and nonclinical toxicology study data using the Standard for Exchange of Nonclinical Data (SEND), a new electronic data standard format which is used to support review activity. FDA anticipates that a successful pilot will enable CVM to accept margin of safety and nonclinical toxicology study data related to investigational new animal drug (INAD) files and new animal drug applications (NADA's) electronically in SEND format. 2009-12-10 2009 12 https://www.federalregister.gov/documents/2009/12/10/E9-29419/electronic-margin-of-safety-and-nonclinical-toxicology-study-data-submission-notice-of-pilot-project https://www.govinfo.gov/content/pkg/FR-2009-12-10/pdf/E9-29419.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) is seeking sponsors interested in participating in a pilot project to test the electronic submission of margin of safety and nonclinical toxicology study data using the...

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