FDA Joint Meeting of DSaRM and PDAC FDA Patient Engagement Advisory Committee Meeting FDA Cardiovascular and Renal Drugs Advisory Committee Meeting FDA: Regulatory Do's and Don'ts (Tips from CDER and CBER) FDA: ICH M12 Drug-Drug...
该指南最终确定了2023年3月16日发布的同名指南草案，并取代了2007年5月发布的题为“临床研究中使用的计算机化系统”的行业指南。研讨会和培训 ICH M12 Drug-Drug Interaction Studies Final Guidance, October 9, 2024 (Hosted by CDER SBIA)美东时间2024年10月9日，FDA CDER举行了题为“ ICH M12 药物相互作用研...
Upcoming：Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources 2023年12月12日至13日，FDA将举办研讨会，此网络研讨会将讨论：1. 评估涉及治疗性蛋白产品的药物相互作用、胃酸pH值变化引起的相互作用以及影响联合口服避孕药的相互作用的重要性。2. 如何评估待研究药物的药物相...
Guidance for Institutions and IRBs Additional copies are available from: Division of Policy and Assurances Office for Human Research Protections 1101 Wootton Parkway, Suite 200 Rockville, MD 20852 (Tel) 240-453-6900 or 866-447-4777 (Fax) 301-402-2071 /ohrp/regulations-and-policy/guidance/...
, Aug. 4, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a new guidance for immediate implementation, "Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related ...
ICH M12 Drug-Drug Interaction Studies Final Guidance, October 9, 2024 (Hosted byCDERSBIA) 美东时间2024年10月9日,FDA CDER举行了题为“ ICH M12 药物相互作用研究最终指南”的研讨会。该网络研讨会将讨论ICH M12药物相互作用研究指南,该指南是第一份全球统一的监管指南,用于评估由代谢酶和药物转运体介导的药...
. Draft Guidance for Industry (GFI) #282, entitled “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals,” outlines the basic elements of informed consent in animal drug clinical studies. The FDA is accepting public comment on th...
1. U.S. FDA. Real-Time Oncology Review (RTOR) Guidance for Industry. 2023.11 2. de Claro RA, Gao JJ, Kim T, et al. U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program. Clin Cancer Res. 2021;27(1):11-14. doi:10.1158/1078-0432.CCR...
In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers Guidance for Industry” (“2023 Draft Guidance”).[1] The 2023 Draft Guidance su...
Upcoming:Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources 2023年12月12日至13日,FDA将举办研讨会,此网络研讨会将讨论:1. 评估涉及治疗性蛋白产品的药物相互作用、胃酸pH值变化引起的相互作用以及影响联合口服避孕药的相互作用的重要性。2. 如何评估待研究药物的药物相互...