{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients.\" This document is intended to provide guidance on the types of toxicity information that FDA recommends be provided to the agency to support the use of new excipients in drug products. Previously, such information was not available to drug sponsors in a written document. This information should allow drug sponsors to determine if a potential new excipient is safe to use in drug products.","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/2005/05/19/05-9957.html","cfr_references":[],"citation":"70 FR 28946","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. 2002D-0389"],"dockets":[],"document_number":"05-9957","effective_on":null,"end_page":28947,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2005/05/19/05-9957.xml","html_url":"https://www.federalregister.gov/documents/2005/05/19/05-9957/guidance-for-industry-on-nonclinical-studies-for-the-safety-evaluation-of-pharmaceutical-excipients","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/05-9957?publication_date=2005-05-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2005-05-19/05-9957/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1786,"last_updated":"2026-08-26 02:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2005-05-19/pdf/05-9957.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2005-05-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2005/05/19/05-9957.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T16:13:35Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28946,"subtype":null,"title":"Guidance for Industry on Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients; Availability","toc_doc":"Nonclinical Studies for Safety Evaluation of Pharmaceutical Excipients","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":70}