{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA).'' This guidance is intended to assist developers of drugs, biological products, or medical devices intended for the treatment of rheumatoid arthritis (RA). It provides guidance on the types of claims that could be considered for such products and on clinical evaluation programs that could support those claims. The guidance also contains recommendations on the timing, design, and conduct of preclinical and clinical trials for RA products and on special considerations for juvenile RA.","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/1999/02/17/99-3776.html","cfr_references":[],"citation":"64 FR 7898","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. 96D-0067"],"dockets":[],"document_number":"99-3776","effective_on":null,"end_page":7899,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1999/02/17/99-3776/guidance-for-industry-on-clinical-development-programs-for-drugs-devices-and-biological-products-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/99-3776?publication_date=1999-02-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1999-02-17/99-3776/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":190,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1999-02-17/pdf/99-3776.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1999-02-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1999/02/17/99-3776.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T00:31:57Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7898,"subtype":null,"title":"Guidance for Industry on Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA); Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":64}