federal_register: 2010-15711

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2010-15711 Change of Address; Abbreviated New Drug Applications; Technical Amendment Rule The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit abbreviated new drug applications (ANDAs) and ANDA amendments, supplements, and resubmissions. FDA is also updating the address for ANDA applicants to submit investigational new drug applications (INDs) for in vivo bioavailability and bioequivalence studies in humans that are intended to support ANDAs. This action is being taken to ensure accuracy and clarity in the agency's regulations. 2010-06-29 2010 6 https://www.federalregister.gov/documents/2010/06/29/2010-15711/change-of-address-abbreviated-new-drug-applications-technical-amendment https://www.govinfo.gov/content/pkg/FR-2010-06-29/pdf/2010-15711.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is amending its regulations to update the address for applicants to submit abbreviated new drug applications (ANDAs) and ANDA amendments, supplements, and resubmissions. FDA is also updating the address for ANDA...

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