{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.\" This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA has determined will likely have a minimal potential to have an adverse effect on product quality and, therefore, should be documented by applicants in an annual report. (The guidance excludes positron emission tomography drug products.)","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/03/05/2014-04811.html","cfr_references":[],"citation":"79 FR 12511","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0283"],"dockets":[],"document_number":"2014-04811","effective_on":null,"end_page":12512,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/03/05/2014-04811.xml","html_url":"https://www.federalregister.gov/documents/2014/03/05/2014-04811/guidance-for-industry-on-chemistry-manufacturing-and-controls-postapproval-manufacturing-changes-to","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-04811?publication_date=2014-03-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-03-05/2014-04811/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1343,"last_updated":"2026-07-26 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-03-05/pdf/2014-04811.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-04811.pdf?1393941282","publication_date":"2014-03-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/03/05/2014-04811.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2010-D-0283","supporting_documents_count":337941,"docket_id":"FDA-2010-D-0283","regulation_id_number":null,"title":"Draft Guidance for Industry on CMC Postapproval Manufacturing Changes Reportable in Annual Reports; Availability","checked_regulationsdotgov_at":"2014-03-25T08:10:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":12511,"subtype":null,"title":"Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes To Be Documented in Annual Reports; Availability","toc_doc":"Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":79}