federal_register: 04-18846

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
04-18846 Presubmission Conferences Rule The Food and Drug Administration (FDA) is issuing this final rule to amend its new animal drug regulations to implement a new provision of the Federal Food, Drug, and Cosmetic Act (the act). Under this new provision of the act, as amended by the Animal Drug Availability Act of 1996 (ADAA), any person intending to file a new animal drug application (NADA) or supplemental NADA or to investigate a new animal drug is entitled to one or more conferences with FDA to reach an agreement establishing a submission or investigational requirement. This final rule describes the procedures for requesting, conducting, and documenting such presubmission conferences. 2004-08-18 2004 8 https://www.federalregister.gov/documents/2004/08/18/04-18846/presubmission-conferences https://www.govinfo.gov/content/pkg/FR-2004-08-18/pdf/04-18846.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is issuing this final rule to amend its new animal drug regulations to implement a new provision of the Federal Food, Drug, and Cosmetic Act (the act). Under this new provision of the act, as amended by the Animal...

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