federal_register: E9-26095

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-26095 Investigational New Drug Applications; Technical Amendment Rule The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations. 2009-10-29 2009 10 https://www.federalregister.gov/documents/2009/10/29/E9-26095/investigational-new-drug-applications-technical-amendment https://www.govinfo.gov/content/pkg/FR-2009-10-29/pdf/E9-26095.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that...

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