{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled \"Q11 Development and Manufacture of Drug Substances--Questions and Answers (regarding the selection and justification of starting materials).\" The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance \"Q11 Development and Manufacture of Drug Substances\". The draft guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The question-and-answer (Q&A) draft guidance focuses on chemical entity drug substances, and provides recommendation on the information that should be provided in marketing authorization applications and/or Master Files to justify the starting materials.","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/2017/02/21/2017-03309.html","cfr_references":[],"citation":"82 FR 11225","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 23, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2017-D-0155"],"dockets":[],"document_number":"2017-03309","effective_on":null,"end_page":11226,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/02/21/2017-03309.xml","html_url":"https://www.federalregister.gov/documents/2017/02/21/2017-03309/q11-development-and-manufacture-of-drug-substances-questions-and-answers-regarding-the-selection-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-03309?publication_date=2017-02-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-02-21/2017-03309/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":754,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-02-21/pdf/2017-03309.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-03309.pdf?1487339143","publication_date":"2017-02-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/02/21/2017-03309.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-2017-D-0155","supporting_documents_count":0,"docket_id":"FDA-2017-D-0155","regulation_id_number":null,"title":"Q11 Development and Manufacture of Drug Substances--Questions and Answers (Regarding the Selection and Justification of Starting Materials); International Council for Harmonisation","checked_regulationsdotgov_at":"2017-03-24T05:00:53Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":11225,"subtype":null,"title":"Q11 Development and Manufacture of Drug Substances-Questions and Answers (Regarding the Selection and Justification of Starting Materials); International Council for Harmonisation; Guidance for Industry; Availability","toc_doc":"Q11 Development and Manufacture of Drug SubstancesQuestions and Answers (Selection and Justification of Starting Materials); International Council for Harmonisation","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":82}