{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.\" This draft guidance provides recommendations to sponsors for assessing risks to embryo/fetal development resulting from administration of an active pharmaceutical ingredient (API) to males either through an effect on the male germ cell or from fetal exposure following seminal transfer of a potentially developmental toxicant to pregnant females. The need for measures to mitigate the risk to embryo/fetal development posed by males participating in clinical trials is also addressed.","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/2015/06/12/2015-14363.html","cfr_references":[],"citation":"80 FR 33526","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 11, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-2001"],"dockets":[],"document_number":"2015-14363","effective_on":null,"end_page":33527,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/06/12/2015-14363.xml","html_url":"https://www.federalregister.gov/documents/2015/06/12/2015-14363/assessment-of-male-mediated-developmental-risk-for-pharmaceuticals-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-14363?publication_date=2015-06-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-06-12/2015-14363/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1395,"last_updated":"2026-06-27 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-06-12/pdf/2015-14363.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-14363.pdf?1434026762","publication_date":"2015-06-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/06/12/2015-14363.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-2015-D-2001","supporting_documents_count":0,"docket_id":"FDA-2015-D-2001","regulation_id_number":null,"title":"Assessment of Male-Mediated Developmental Risk for Pharmaceuticals","checked_regulationsdotgov_at":"2015-08-12T05:00:38Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33526,"subtype":null,"title":"Assessment of Male-Mediated Developmental Risk for Pharmaceuticals; Draft Guidance for Industry; Availability","toc_doc":"Assessment of Male-Mediated Developmental Risk for Pharmaceuticals","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":80}