{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Expedited Programs for Serious Conditions--Drugs and Biologics.\" The purpose of this draft guidance is to provide a single resource for information on FDA's policies and procedures related to expedited drug development and review programs. The following programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of serious or life-threatening conditions (expedited programs): Fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation.","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/2013/06/26/2013-15250.html","cfr_references":[],"citation":"78 FR 38349","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 26, 2013. Submit either electronic or written comments concerning the proposed collection of information by August 26, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0575"],"dockets":[],"document_number":"2013-15250","effective_on":null,"end_page":38351,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/06/26/2013-15250.xml","html_url":"https://www.federalregister.gov/documents/2013/06/26/2013-15250/draft-guidance-for-industry-on-expedited-programs-for-serious-conditions-drugs-and-biologics","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-15250?publication_date=2013-06-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-06-26/2013-15250/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":3373,"last_updated":"2026-08-24 06:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-06-26/pdf/2013-15250.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-15250.pdf?1372164602","publication_date":"2013-06-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/06/26/2013-15250.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2013-08-04T05:01:24Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":38349,"subtype":null,"title":"Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics; Availability","toc_doc":"Expedited Programs for Serious ConditionsDrugs and Biologics; Availability","toc_subject":"Draft Guidance for Industry:","topics":[],"type":"Notice","volume":78}