{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Early Alzheimer's Disease: Developing Drugs for Treatment.\" This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia. This guidance revises the draft guidance for industry entitled \"Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease\" issued February 8, 2013.","action":"Notice of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/2018/02/16/2018-03226.html","cfr_references":[],"citation":"83 FR 7060","comment_url":null,"comments_close_on":"2018-05-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by May 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2013-D-0077"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":19,"comment_start_date":"2018-02-16","updated_at":"2023-02-28T15:05:27.577-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-D-0077-0042","allow_late_comments":null,"id":"FDA-2013-D-0077-0042","comment_end_date":"2018-05-18","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":"2018-03226","effective_on":null,"end_page":7061,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/02/16/2018-03226.xml","html_url":"https://www.federalregister.gov/documents/2018/02/16/2018-03226/early-alzheimers-disease-developing-drugs-for-treatment-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-03226?publication_date=2018-02-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-02-16/2018-03226/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1945,"last_updated":"2026-08-25 18:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-02-16/pdf/2018-03226.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-03226.pdf?1518702351","publication_date":"2018-02-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/02/16/2018-03226.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":19,"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-0077-0042","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":7060,"subtype":null,"title":"Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Early Alzheimer's DiseaseDeveloping Drugs for Treatment","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}