{"abstract":"The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD) is updating drug manufacturers on OGD efforts to review policy and procedure guides (PPGs) and other existing OGD documents that provide guidance on the development of generic drug products. We are also announcing the withdrawal of a list of PPGs that have become obsolete or have been replaced with other guidances or agency directives (manuals for policy and procedures (MaPPs)).","action":"Notice; update and withdrawal of guidances.","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/2003/10/27/03-26964.html","cfr_references":[],"citation":"68 FR 61222","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 1999D-1938"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":3,"comment_start_date":"2003-10-27","updated_at":"2025-06-10T07:55:49.587-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-1999-D-0135-0001","allow_late_comments":false,"id":"FDA-1999-D-0135-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-1999-D-0135","title":"Development of Generic Drug Products"}],"document_number":"03-26964","effective_on":null,"end_page":61223,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2003/10/27/03-26964.xml","html_url":"https://www.federalregister.gov/documents/2003/10/27/03-26964/review-and-revision-of-guidances-for-industry-on-the-development-of-generic-drug-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/03-26964?publication_date=2003-10-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2003-10-27/03-26964/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":863,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2003-10-27/pdf/03-26964.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2003-10-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2003/10/27/03-26964.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":3,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-1999-D-0135","supporting_documents_count":0,"docket_id":"FDA-1999-D-0135","document_id":"FDA-1999-D-0135-0001","regulation_id_number":null,"title":"Development of Generic Drug Products","checked_regulationsdotgov_at":"2025-06-11T14:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61222,"subtype":null,"title":"Review and Revision of Guidances for Industry on the Development of Generic Drug Products; Development and Use of Food and Drug Administration Guidance Documents; Update and Withdrawal of Guidances","toc_doc":"Generic drug products development; guidance documents development and use; update and withdrawal of guidances","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":68}