{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.\" This guidance document finalizes the revised draft of the same name that published on October 30, 2015. This guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs), reviewed by the Center for Drug Evaluation and Research (CDER).","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/2018/04/05/2018-06926.html","cfr_references":[],"citation":"83 FR 14642","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on April 5, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2002-D-0093"],"dockets":[],"document_number":"2018-06926","effective_on":null,"end_page":14643,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/04/05/2018-06926.xml","html_url":"https://www.federalregister.gov/documents/2018/04/05/2018-06926/liposome-drug-products-chemistry-manufacturing-and-controls-human-pharmacokinetics-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-06926?publication_date=2018-04-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-04-05/2018-06926/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":374,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-04-05/pdf/2018-06926.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-06926.pdf?1522845923","publication_date":"2018-04-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/04/05/2018-06926.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2002-D-0093","supporting_documents_count":0,"docket_id":"FDA-2002-D-0093","regulation_id_number":null,"title":"Liposome Drug Products:Chemistry, Manufacturing, and Control","checked_regulationsdotgov_at":"2018-04-25T10:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14642,"subtype":null,"title":"Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Guidance for Industry; Availability","toc_doc":"Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}