{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled \"Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry.\" The guidance document provides investigational new drug application (IND) sponsors with recommendations regarding IND submissions for early clinical trials with live biotherapeutic products (LBPs) in the United States. The guidance announced in this notice updates the guidance of the same title dated February 2012 (February 2012 guidance) by addressing when the label on the commercially available products(s) would be considered adequate to satisfy the purpose of the chemistry, manufacturing, and control (CMC) information requirements.","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/2016/07/01/2016-15664.html","cfr_references":[],"citation":"81 FR 43206","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-D-0500"],"dockets":[],"document_number":"2016-15664","effective_on":null,"end_page":43207,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/01/2016-15664.xml","html_url":"https://www.federalregister.gov/documents/2016/07/01/2016-15664/early-clinical-trials-with-live-biotherapeutic-products-chemistry-manufacturing-and-control","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-15664?publication_date=2016-07-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-01/2016-15664/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1034,"last_updated":"2026-04-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/2016-15664.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-15664.pdf?1467290961","publication_date":"2016-07-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/01/2016-15664.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 18 - Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufactu","document_id":"FDA-2010-D-0500-0036"},{"title":"Reference 17 - Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745(a) of the Federal Food, Drug and Cosmetic Act; Guidance for Industry re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing,","document_id":"FDA-2010-D-0500-0035"},{"title":"Reference 16 -  Providing Regulatory Submissions in Electronic Format - Standardized Study Data; Guidance for Industry re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information","document_id":"FDA-2010-D-0500-0034"},{"title":"Reference 15 - Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Inform","document_id":"FDA-2010-D-0500-0033"},{"title":"Reference 14 - E8 General Considerations for Clinical Trials re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information","document_id":"FDA-2010-D-0500-0032"},{"title":"Reference 13 - Guidance for Industry Studies in Support of Special Populations Geriatrics re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information","document_id":"FDA-2010-D-0500-0031"},{"title":"Reference 12 - Guidance for Industry  E11 Clinical Investigation of Medicinal Products in the Pediatric Population re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information","document_id":"FDA-2010-D-0500-0030"},{"title":"Reference 11 - Guidance for Industry E6 Clinical Practice - Consolidated Guidance re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information","document_id":"FDA-2010-D-0500-0029"},{"title":"Reference 10 - Guidance for Industry M3(R2) Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Athorization for Pharmaceuticals re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Contr","document_id":"FDA-2010-D-0500-0028"},{"title":"Reference 9 - Guidance for Industry S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharamceuticals re Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information","document_id":"FDA-2010-D-0500-0027"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2010-D-0500","supporting_documents_count":21,"docket_id":"FDA-2010-D-0500","regulation_id_number":null,"title":"Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information","checked_regulationsdotgov_at":"2016-07-21T06:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43206,"subtype":null,"title":"Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry; Availability","toc_doc":"Early Clinical Trials With Live Biotherapeutic Products:  Chemistry, Manufacturing, and Control Information","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}