{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled \"ANDAs: Stability Testing of Drug Substances and Products.\" FDA is recommending generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonisation (ICH) guidances Q1A (R2) through Q1E. The use of these ICH recommendations will standardize FDA's stability testing policies, which will help make the abbreviated new drug application (ANDA) review process more efficient.","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/2013/06/20/2013-14674.html","cfr_references":[],"citation":"78 FR 37231","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-2012-D-0938"],"dockets":[],"document_number":"2013-14674","effective_on":null,"end_page":37232,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/06/20/2013-14674.xml","html_url":"https://www.federalregister.gov/documents/2013/06/20/2013-14674/guidance-for-industry-guidance-on-abbreviated-new-drug-applications-stability-testing-of-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-14674?publication_date=2013-06-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-06-20/2013-14674/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1435,"last_updated":"2026-07-26 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-06-20/pdf/2013-14674.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-14674.pdf?1371646472","publication_date":"2013-06-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/06/20/2013-14674.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-2012-D-0938","supporting_documents_count":0,"docket_id":"FDA-2012-D-0938","regulation_id_number":null,"title":"Draft Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products; Availability","checked_regulationsdotgov_at":"2013-07-10T08:07:48Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37231,"subtype":null,"title":"Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability","toc_doc":"Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products","toc_subject":"Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}