federal_register: E7-10515

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E7-10515 Guidance for Industry: Chemistry, Manufacturing, and Control Changes to an Approved New Animal Drug Application or Abbreviated New Animal Drug Application Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (<greek-i>83) entitled "Chemistry, Manufacturing, and Control Changes to an Approved NADA or ANADA." This guidance is intended to provide recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) on how they should report certain changes to such applications, in accordance with the final regulation, 21 CFR 514.8, which was issued in the Federal Register of December 13, 2006 (71 FR 74766). 2007-05-31 2007 5 https://www.federalregister.gov/documents/2007/05/31/E7-10515/guidance-for-industry-chemistry-manufacturing-and-control-changes-to-an-approved-new-animal-drug https://www.govinfo.gov/content/pkg/FR-2007-05-31/pdf/E7-10515.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (<greek-i>83) entitled "Chemistry, Manufacturing, and Control Changes to an Approved NADA or ANADA." This guidance is intended to provide recommendations...

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