{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a document entitled \"Guidance for Industry: CGMP for Phase 1 Investigational Drugs\" dated July 2008. The guidance provides assistance in applying relevant current good manufacturing practice (CGMP) requirements of the Federal Food, Drug, and Cosmetic Act (the act) to the manufacture of most investigational new drugs, including biological drugs, used in phase 1 clinical trials. FDA is issuing this guidance concurrently with a final rule published elsewhere in this issue of the Federal Register specifying that compliance with FDA's CGMP regulations is not required for most investigational drugs that are manufactured for use in phase 1 clinical trials. Therefore, FDA is recommending the approaches outlined in this guidance for complying with the statutory CGMP requirements in the act. The guidance announced in this notice finalizes the draft guidance entitled \"INDs--Approaches to Complying with CGMP During Phase 1\" dated January 2006.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND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/2008/07/15/E8-16002.html","cfr_references":[],"citation":"73 FR 40584","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. FDA-2005-D-0157"],"dockets":[],"document_number":"E8-16002","effective_on":null,"end_page":40585,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2008/07/15/E8-16002.xml","html_url":"https://www.federalregister.gov/documents/2008/07/15/E8-16002/guidance-for-industry-current-good-manufacturing-practice-for-phase-1-investigational-drugs","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E8-16002?publication_date=2008-07-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2008-07-15/E8-16002/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1803,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2008-07-15/pdf/E8-16002.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2008-07-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2008/07/15/E8-16002.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-14T11:44:41Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40584,"subtype":null,"title":"Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs; Availability","toc_doc":"Current Good Manufacturing Practice for Phase 1 Investigational Drugs; Availability","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":73}