{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.\" This guidance outlines FDA's current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease that occur before the onset of overt dementia.","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/2013/02/08/2013-02863.html","cfr_references":[],"citation":"78 FR 9396","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 9, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-0077"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":37,"comment_start_date":"2013-02-08","updated_at":"2024-03-18T11:56:05.723-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-D-0077-0001","allow_late_comments":null,"id":"FDA-2013-D-0077-0001","comment_end_date":"2013-04-10","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2013-D-0077","title":"Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease"}],"document_number":"2013-02863","effective_on":null,"end_page":9397,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/02/08/2013-02863.xml","html_url":"https://www.federalregister.gov/documents/2013/02/08/2013-02863/draft-guidance-for-industry-on-alzheimers-disease-developing-drugs-for-the-treatment-of-early-stage","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-02863?publication_date=2013-02-08","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-02-08/2013-02863/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1086,"last_updated":"2026-07-26 04:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-02-08/pdf/2013-02863.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-02863.pdf?1360244913","publication_date":"2013-02-08","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/02/08/2013-02863.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":37,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-0077","supporting_documents_count":0,"docket_id":"FDA-2013-D-0077","document_id":"FDA-2013-D-0077-0001","regulation_id_number":null,"title":"Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease","checked_regulationsdotgov_at":"2024-03-19T15:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":9396,"subtype":null,"title":"Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease; Availability","toc_doc":"Alzheimer's Disease; Developing Drugs for the Treatment of Early Stage Disease","toc_subject":"Draft Guidances for Industry; Availability:","topics":[],"type":"Notice","volume":78}