{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"ANDAs: Stability Testing of Drug Substances and Products.\" FDA is recommending that generic drug manufacturers follow the stability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/2012/09/25/2012-23543.html","cfr_references":[],"citation":"77 FR 58999","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 24, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0938"],"dockets":[],"document_number":"2012-23543","effective_on":null,"end_page":59000,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/09/25/2012-23543.xml","html_url":"https://www.federalregister.gov/documents/2012/09/25/2012-23543/draft-guidance-for-industry-on-abbreviated-new-drug-applications-stability-testing-of-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-23543?publication_date=2012-09-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-09-25/2012-23543/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1058,"last_updated":"2026-10-22 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-09-25/pdf/2012-23543.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-23543.pdf?1348490989","publication_date":"2012-09-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/09/25/2012-23543.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":"2012-11-18T05:01:29Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":58999,"subtype":null,"title":"Draft Guidance for Industry 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":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":77}