{"abstract":"The Food and Drug Administration (FDA) is publishing a draft revised guidance entitled \"Q1A(R) Stability Testing of New Drug Substances and Products.\" The draft revised guidance, which updates a guidance on the same topic published in the Federal Register of September 22, 1994 (the 1994 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft revised guidance clarifies the 1994 guidance, adds information, and provides consistency with more recently published ICH guidances. The draft revised guidance is intended to reflect formal scientific principles for stability testing of drugs and should be useful to applicants submitting new drug applications for new molecular entities and associated 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/2000/04/21/00-9942.html","cfr_references":[],"citation":"65 FR 21446","comment_url":null,"comments_close_on":"2000-06-05","correction_of":null,"corrections":[],"dates":"Submit written comments by June 5, 2000.","disposition_notes":null,"docket_ids":["Docket No. 93D-0139"],"dockets":[],"document_number":"00-9942","effective_on":null,"end_page":21453,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2000/04/21/00-9942.xml","html_url":"https://www.federalregister.gov/documents/2000/04/21/00-9942/international-conference-on-harmonisation-draft-revised-guidance-on-q1ar-stability-testing-of-new","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/00-9942?publication_date=2000-04-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2000-04-21/00-9942/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":1279,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2000-04-21/pdf/00-9942.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2000-04-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2000/04/21/00-9942.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":21446,"subtype":null,"title":"International Conference on Harmonisation; Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and Products","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":65}