The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs...
Today, FDA published the new draft guidance for industry, “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.” This guidance is intended to assist...
Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence StudiesSponsor Responsibilities — Safety Reporting Requirements and Safety ...
Expanded Access to Investigational Drugs for Treatment Use: Questions and AnswersOctober 2025 Final Level 1 Revised GuidanceSearch for FDA Guidance DocumentsCross-cutting Guidance DocumentsSearch G...
Conducting Clinical Trials With Decentralized ElementsSeptember 2024Final Level 1 GuidanceSearch for FDA Guidance DocumentsSearch General and Cross-Cutting Topics Guidance DocumentsAdvisory Committ...
The purpose of this guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs ...
Myelodysplastic Syndromes: Developing Drug and Biological Products for TreatmentDraft Guidance for IndustryJuly 2025 DraftNot for implementation. Contains non-binding recommendations.This guidance ...
For Immediate Release:April 10, 2025Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclona...
美国食品和药物管理局（FDA或机构）宣布发布一份题为“E6（R3）良好临床实践：附件2”的行业指南草案。该指南草案是在国际人用药品技术要求协调理事会（ICH）的主持下编写的。该指南草案是2023年6月发布的“E6（R3）良好临床实践”的第二个附件。本附件为将良好临床实践应用于各种试验设计和数据源提供了额外的考虑因素。具体而言，本指南草案讨论了具有分散和实用元素以及现实世界数据源的试验。本指南...
本指南为增加女性参与临床试验、分析和解释性别特异性数据以及在医疗产品的监管提交中纳入性别特异性信息提供了建议。医疗产品的临床试验和非干预性研究应设计为招募足够数量的女性和男性，以反映医疗产品所调查的疾病或病症的患病率，以帮助确保结果的普遍性，并促进对性别影响的潜在差异的探索。最终确定后，本指南将取代1993年7月发布的题为“药物临床评价中性别差异的研究和评价指南”的指南。Study of S...
本指南为行业、研究人员、机构和机构审查委员会（IRB）提供了关于组织活检考虑因素的建议，这些组织活检可能是评估研究性医疗产品和/或由卫生与公众服务部（HHS）进行或支持的临床试验的一部分，用于成人和儿童。就本指南而言，活检是一种涉及从试验参与者身上采集组织的程序，作为临床试验方案的一部分。本指南不包括为常规临床护理提供信息所需的活组织检查。Considerations for Includi...
本指南提供了建议，以协助申办方、临床研究人员和机构审查委员会（IRB）定义、识别和报告临床研究中的方案偏差。美国食品药品监督管理局的规定不包括对“方案偏离”一词的定义，也不提供对临床研究过程中可能发生的各种偏离进行分类的系统。应用一致的分类、报告和文件标准的系统对于确保从方案偏离报告中获得最可解释和最有用的信息非常重要。为了解决这些问题，本指南包括方案偏离和重要方案偏离的定义、申办方应在药物...
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and AnswersOCTOBER 2024Download the Final Guidance Document Read the Federal Register NoticeF...
On September 19, 2024, the Food and Drug Administration approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for adult patients with locally advanced or meta...
Docket Number:FDA-2024-D-2052Issued by:Center for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchOncology Center of ExcellenceAs part of FDA’s Real-World Evidence (RWE) Pro...
Docket Number:FDA-2022-D-2870Issued by:Center for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthOncology Center of ExcellenceThis...
今天，美国食品和药物管理局发布了一份行业指南草案，该草案定稿后，将为申办方提供进行多区域临床试验（MRCT）的建议，以支持用于治疗癌症的药物申请。MRCT是在单一方案下在多个地区进行的试验，地区/区域定义为地理区域、国家或监管区域。“美国食品药品监督管理局鼓励申办方进行多地区临床试验，但强调此类试验应在适当的背景下进行，”美国食品药品监管局肿瘤卓越中心主任、美国食品药品管理局药物评估和研究中...
On September 17, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metast...
On September 17, 2024, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) with an aromatase inhibitor for the adjuvant treatment of adults with hor...
