{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information.\" This draft guidance is intended to assist sponsors in determining whether it may be appropriate to rely on generally accepted scientific knowledge (GASK) to fulfill certain legal and regulatory requirements applicable to the new drug application (NDA) or biologics licensing application (BLA) in question. When final, this guidance will represent the Agency's current thinking on this topic.","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/2023/05/25/2023-11148.html","cfr_references":[],"citation":"88 FR 33887","comment_url":null,"comments_close_on":"2023-07-24","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 24, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2023-D-1618"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-05-25","updated_at":"2023-05-25T09:56:47.009-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-1618-0001","allow_late_comments":null,"id":"FDA-2023-D-1618-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-1618","title":"Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry; Availability"}],"document_number":"2023-11148","effective_on":null,"end_page":33888,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/05/25/2023-11148.xml","html_url":"https://www.federalregister.gov/documents/2023/05/25/2023-11148/generally-accepted-scientific-knowledge-in-applications-for-drug-and-biological-products-nonclinical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-11148?publication_date=2023-05-25","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-05-25/2023-11148/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":464,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-05-25/pdf/2023-11148.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-11148.pdf?1684932325","publication_date":"2023-05-25","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/05/25/2023-11148.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-2023-D-1618","supporting_documents_count":0,"docket_id":"FDA-2023-D-1618","document_id":"FDA-2023-D-1618-0001","regulation_id_number":null,"title":"Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-05-26T14:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":33887,"subtype":null,"title":"Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information; Draft Guidance for Industry; Availability","toc_doc":"Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}