{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk--Questions and Answers.\" The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance provides a practical approach that is applicable to the identification, categorization, qualification, and control of mutagenic impurities to limit potential carcinogenic risk. Since the ICH M7 Guideline was finalized, the worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities. To facilitate the implementation of the ICH M7 Guideline, the ICH M7 Implementation Working Group has developed a series of questions and answers (Q&As). The scope of this draft Q&A guidance follows that of the ICH M7 Guideline. The draft Q&A guidance is intended to clarify, promote the convergence of, and improve the harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided when developing drugs, completing marketing authorization applications, and using drug master files.","action":"Notice of availability.","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/2020/09/29/2020-21461.html","cfr_references":[],"citation":"85 FR 61009","comment_url":null,"comments_close_on":"2020-12-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 28, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-N-1790"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2020-09-29","updated_at":"2023-03-01T00:14:21.880-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-N-1790-0001","allow_late_comments":null,"id":"FDA-2020-N-1790-0001","comment_end_date":"2020-12-29","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-N-1790","title":"M7 Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk--Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability"}],"document_number":"2020-21461","effective_on":null,"end_page":61011,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/09/29/2020-21461.xml","html_url":"https://www.federalregister.gov/documents/2020/09/29/2020-21461/m7-assessment-and-control-of-deoxyribonucleic-acid-reactive-mutagenic-impurities-in-pharmaceuticals","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-21461?publication_date=2020-09-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-09-29/2020-21461/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":509,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-09-29/pdf/2020-21461.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-21461.pdf?1601297138","publication_date":"2020-09-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/09/29/2020-21461.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-N-1790","supporting_documents_count":0,"docket_id":"FDA-2020-N-1790","document_id":"FDA-2020-N-1790-0001","regulation_id_number":null,"title":"M7 Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk--Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-03-01T05:14:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61009,"subtype":null,"title":"M7 Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability","toc_doc":"M7 Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}