{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers.\" This draft guidance clarifies stability testing recommendations for abbreviated new drug applications (ANDAs) by providing responses to public comments in a questions-and-answers format. This draft guidance addresses public comments regarding FDA's recommendation to generic drug manufacturers to follow International Conference on Hamonisation (ICH) stability guidances Q1A (R2) through Q1E.","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/2013/08/27/2013-20893.html","cfr_references":[],"citation":"78 FR 52931","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 28, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-D-0938"],"dockets":[],"document_number":"2013-20893","effective_on":null,"end_page":52932,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/08/27/2013-20893.xml","html_url":"https://www.federalregister.gov/documents/2013/08/27/2013-20893/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/2013-20893?publication_date=2013-08-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-08-27/2013-20893/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":934,"last_updated":"2026-09-20 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-08-27/pdf/2013-20893.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-20893.pdf?1377521845","publication_date":"2013-08-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/08/27/2013-20893.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":"2013-10-30T05:01:14Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52931,"subtype":null,"title":"Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability","toc_doc":"Abbreviated New Drug Applications; Stability Testing of Drug Substances and Products, Questions and Answers","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}