{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled \"Guidance for Industry: Somatic Cell Therapy for Cardiac Disease\" dated March 2009. The draft guidance document provides sponsors of cellular therapies for the treatment of cardiac disease with recommendations on the design of preclinical and clinical studies, and information that should be submitted about the product delivery system. This guidance also provides recommendations on the chemistry, manufacturing and controls information to include in an investigational new drug application (IND) for cardiac cellular therapy.","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/2009/04/02/E9-7350.html","cfr_references":[],"citation":"74 FR 14992","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by July 1, 2009.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-D-0132"],"dockets":[],"document_number":"E9-7350","effective_on":null,"end_page":14992,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/04/02/E9-7350.xml","html_url":"https://www.federalregister.gov/documents/2009/04/02/E9-7350/draft-guidance-for-industry-somatic-cell-therapy-for-cardiac-disease-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-7350?publication_date=2009-04-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-04-02/E9-7350/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":49,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-04-02/pdf/E9-7350.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-04-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/04/02/E9-7350.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14992,"subtype":null,"title":"Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease; Availability","toc_doc":"Somatic Cell Therapy for Cardiac Disease","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":74}