{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.\" This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations. This guidance finalizes the draft guidance of the same title issued on August 1, 2019.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2022/07/27/2022-16076.html","cfr_references":[],"citation":"87 FR 45110","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on July 27, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-3132"],"dockets":[{"supporting_documents":[{"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry - Final Guidance","document_id":"FDA-2019-D-3132-0009"},{"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Guidance for Industry; Availability","document_id":"FDA-2019-D-3132-0008"},{"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry","document_id":"FDA-2019-D-3132-0002"},{"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Draft Guidance for Industry;  Availability","document_id":"FDA-2019-D-3132-0001"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2022-07-27","updated_at":"2023-02-27T19:30:43.498-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-3132-0008","allow_late_comments":null,"id":"FDA-2019-D-3132-0008","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":4,"id":"FDA-2019-D-3132","title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Draft Guidance for Industry; Availability "}],"document_number":"2022-16076","effective_on":null,"end_page":45111,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/07/27/2022-16076.xml","html_url":"https://www.federalregister.gov/documents/2022/07/27/2022-16076/general-clinical-pharmacology-considerations-for-neonatal-studies-for-drugs-and-biological-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-16076?publication_date=2022-07-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-07-27/2022-16076/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":363,"last_updated":"2026-09-20 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-07-27/pdf/2022-16076.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-16076.pdf?1658839523","publication_date":"2022-07-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/07/27/2022-16076.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry - Final Guidance","document_id":"FDA-2019-D-3132-0009"},{"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Guidance for Industry; Availability","document_id":"FDA-2019-D-3132-0008"},{"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry","document_id":"FDA-2019-D-3132-0002"},{"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Draft Guidance for Industry;  Availability","document_id":"FDA-2019-D-3132-0001"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-D-3132","supporting_documents_count":4,"docket_id":"FDA-2019-D-3132","document_id":"FDA-2019-D-3132-0008","regulation_id_number":null,"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Draft Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-02-28T00:30:42Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45110,"subtype":null,"title":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products; Guidance for Industry; Availability","toc_doc":"General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}