{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment.\" The draft guidance details FDA's recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease (sGERD) in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.","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/2025/09/17/2025-18000.html","cfr_references":[],"citation":"90 FR 44828","comment_url":null,"comments_close_on":"2025-11-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 17, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2025-D-0331"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-09-17","updated_at":"2025-09-17T09:59:28.065-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-D-0331-0001","allow_late_comments":false,"id":"FDA-2025-D-0331-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-D-0331","title":"Symptomatic Nonerosive Gastroesophageal Reflux Disease:  Developing Drugs for Treatment; Draft Guidance for Industry; Availability"}],"document_number":"2025-18000","effective_on":null,"end_page":44829,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/09/17/2025-18000.xml","html_url":"https://www.federalregister.gov/documents/2025/09/17/2025-18000/symptomatic-nonerosive-gastroesophageal-reflux-disease-developing-drugs-for-treatment-draft-guidance","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-18000?publication_date=2025-09-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-09-17/2025-18000/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":127,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-17/pdf/2025-18000.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18000.pdf?1758026717","publication_date":"2025-09-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/09/17/2025-18000.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-D-0331","supporting_documents_count":0,"docket_id":"FDA-2025-D-0331","document_id":"FDA-2025-D-0331-0001","regulation_id_number":null,"title":"Symptomatic Nonerosive Gastroesophageal Reflux Disease:  Developing Drugs for Treatment; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2025-09-18T16:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":44828,"subtype":null,"title":"Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}