{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations.\" FDA is publishing this draft guidance to help sponsor-investigators (hereafter referred to as sponsors) developing individualized antisense oligonucleotide (ASO) drug products for a severely debilitating or life-threatening genetic disease. Most often, individuals with such diseases will not have adequate alternative therapy available for treating their disease. This draft guidance is intended to help sponsors of such development programs, who may be relatively unfamiliar with FDA regulations, processes, and practices, with the administrative and procedural aspects of interacting with FDA, including seeking feedback from FDA on their development programs and making regulatory submissions related to these development programs.","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/2021/01/05/2020-29119.html","cfr_references":[],"citation":"86 FR 314","comment_url":null,"comments_close_on":"2021-03-08","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 8, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-D-2199"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":5,"comment_start_date":"2021-01-05","updated_at":"2023-02-28T13:12:13.438-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-2199-0001","allow_late_comments":null,"id":"FDA-2020-D-2199-0001","comment_end_date":"2021-03-09","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-2199","title":"IND Submissions for Individualized Antisense Oligonucleotide Drug Products:  Administrative and Procedural Recommendations; Draft Guidance for Sponsor-Investigators; Availability"}],"document_number":"2020-29119","effective_on":null,"end_page":315,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/01/05/2020-29119.xml","html_url":"https://www.federalregister.gov/documents/2021/01/05/2020-29119/investigational-new-drug-submissions-for-individualized-antisense-oligonucleotide-drug-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-29119?publication_date=2021-01-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-01-05/2020-29119/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":672,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-01-05/pdf/2020-29119.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-29119.pdf?1609767916","publication_date":"2021-01-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/01/05/2020-29119.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":5,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-D-2199","supporting_documents_count":0,"docket_id":"FDA-2020-D-2199","document_id":"FDA-2020-D-2199-0001","regulation_id_number":null,"title":"IND Submissions for Individualized Antisense Oligonucleotide Drug Products:  Administrative and Procedural Recommendations; Draft Guidance for Sponsor-Investigators; Availability","checked_regulationsdotgov_at":"2023-02-28T18:12:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":314,"subtype":null,"title":"Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations; Draft Guidance for Sponsor-Investigators; Availability","toc_doc":"Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":86}