{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.\" The purpose of this draft guidance is to assist sponsors of drug and biological products for the treatment of rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Drug development for rare diseases has many challenges related to the nature of these diseases. This draft guidance is intended to advance and facilitate the development of drugs and biological products for the treatment of rare diseases.","action":"Notice of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/2018/10/16/2018-22435.html","cfr_references":[],"citation":"83 FR 52223","comment_url":null,"comments_close_on":"2018-12-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by December 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-3268"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":6,"comment_start_date":"2018-10-16","updated_at":"2023-03-01T03:01:04.131-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-3268-0001","allow_late_comments":null,"id":"FDA-2018-D-3268-0001","comment_end_date":"2018-12-18","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-3268","title":"Rare Diseases:  Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings; Draft Guidance for Industry; Availability "}],"document_number":"2018-22435","effective_on":null,"end_page":52224,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/10/16/2018-22435.xml","html_url":"https://www.federalregister.gov/documents/2018/10/16/2018-22435/rare-diseases-early-drug-development-and-the-role-of-pre-investigational-new-drug-application","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-22435?publication_date=2018-10-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-10-16/2018-22435/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":772,"last_updated":"2026-07-27 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-10-16/pdf/2018-22435.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-22435.pdf?1539607521","publication_date":"2018-10-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/10/16/2018-22435.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":6,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-3268","supporting_documents_count":0,"docket_id":"FDA-2018-D-3268","document_id":"FDA-2018-D-3268-0001","regulation_id_number":null,"title":"Rare Diseases:  Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-03-01T08:01:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52223,"subtype":null,"title":"Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings; Draft Guidance for Industry; Availability","toc_doc":"Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}