{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.\" This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.","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/2018/04/09/2018-07151.html","cfr_references":[],"citation":"83 FR 15161","comment_url":null,"comments_close_on":"2018-06-08","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by June 8, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2018-D-1201"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":49,"comment_start_date":"2018-04-09","updated_at":"2023-02-28T21:31:52.634-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1201-0001","allow_late_comments":null,"id":"FDA-2018-D-1201-0001","comment_end_date":"2018-06-09","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-1201","title":"Pregnant Women:  Scientific and Ethical Considerations for Inclusion in Clinical Trials"}],"document_number":"2018-07151","effective_on":null,"end_page":15162,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/04/09/2018-07151.xml","html_url":"https://www.federalregister.gov/documents/2018/04/09/2018-07151/pregnant-women-scientific-and-ethical-considerations-for-inclusion-in-clinical-trials-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-07151?publication_date=2018-04-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-04-09/2018-07151/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":3122,"last_updated":"2026-10-25 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-04-09/pdf/2018-07151.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-07151.pdf?1523018728","publication_date":"2018-04-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/04/09/2018-07151.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":49,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-1201","supporting_documents_count":0,"docket_id":"FDA-2018-D-1201","document_id":"FDA-2018-D-1201-0001","regulation_id_number":null,"title":"Pregnant Women:  Scientific and Ethical Considerations for Inclusion in Clinical Trials","checked_regulationsdotgov_at":"2023-03-01T02:31:51Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":15161,"subtype":null,"title":"Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance; Availability","toc_doc":"Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}