I. INTRODUCTION This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under section 351(k) of the Public Health Service Act (PHS Act) (...
美国FDA 指导原则 针对IRBS指导文件的不良事件报告 英文原版.pdf,Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection U.S. Department of Health and Human Services Food and Drug Adminis
The proposed guidance expresses the CDER’s and the Center for Biologics Evaluation and Research’s (CBER) current thinking regarding benefit-risk assessments, which now includes how patient experience will be used when considering the benefit-risk assessment. Patient experience ...
· As stated in the guidance for industry and investigators Safety Reporting Requirements for INDs and BA/BE Studies (December 2012), FDA recommends unblinding the patient and the investigator when the patient has an adverse event suspected to be related to the investigational drug product and for ...
III. SCOPE This guidance provides an overview of important scientific considerations in demonstrating interchangeability with a reference product, including the following: Data and information needed to support a demonstration of interchangeability Considerations for the design and analysis of a swi...
The enrollment of healthy volunteers warrants a very low tolerance for risk in those clinical trials. This guidance provides you, sponsors, monitors, and investigators of vaccine trials, with recommendations on assessing the severity of clinical and laboratory abnormalities in healthy adult and ...
This guidance does not address all issues relating to clinical trial design, statistical analysis, or the biomarker development process. Those topics are addressed in the International Conference on Harmonisation (ICH) guidances for industry E9 Statistical Principles for Clinical Trials and E10 Choice of...
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you analyze for your customers. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP...
The ADRG should be file-tagged as ‘analysis-data-definition’, with a clear leaf title.用于临床研究的ADRG应与eCTD模块5中的分析数据一起放置。ADRG应将文件标记为“分析数据定义”,并带有明确的叶子标题。 • An ADRG for clinical data should be called an ADRG and the document should be a ...
The FDA will continue to provide guidance and oversight to ensure product sponsor studies are carried out in a complete and timely manner. We are constantly seeking new methods for improving our surveillance practices, and we invite the public to comment on the draft document released...