美国FDA 指导原则 美国食品药品监督管理局新冠肺炎期间医疗产品临床试验指南行业、调查人员和机构审查委员会指南 英文原版.pdf,Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, and I
POST-OR PRE- MARKET SURVEILLANCE:销售前或销售后监督 INFORMED CONSENT:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验) OTC DRUG(OVER—THE—COUNTER DRUG):非处方药 NIH(NATIONAL INSTITUTE OF HEALTH):(美国)全国卫生研究所 CLINICAL TRIAL:临床试验 ANIMAL TRIAL:动物试验 ACCELERATED APPRO...
if the subject is or may becomepregnant) that are currently unforeseeable (21 CFR 50.25(b)(1)). Iflong-term safetystudies (such as bench and animal testing) are not completed, the informed consent process should
Reviewing the informed consent form and the informed consent process,8 including: • Consideration of the required and additional elements of informed consent. • Translation of the informed consent form for non-English speaking subjects, when applicable. • For HHS-conducted or -supported ...
FDA details compliance for informed consentThe article presents information on a guidance issued by the U.S. Food and Drug Administration for complying with regulations regarding a consent document related to clin...
Given this public health emergency, and as discussed in theNotice in the Federal Register of March 25, 2020, titled “Process forMaking Available Guidance Documents Related to Coronavirus Disease 2019,” availableat https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf,this gui...
manufacture,process,pack,hold,生产,加工,包装,贮存 responsibilityandauthority职责和权力 approveorreject/withhold批准和拒收 reviewproductionrecords复查生产记录 eachshipment每装货量 accommodation() 车,船,飞机等的预定铺位 objectionablemicroorganism有害微生物 thenumberofunits联合批号 accuracy,sensitivity,specificity,an...
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards 2024年3月1日，FDA发布了一份题为“申办方、研究者和机构审查委员会知情同意指南中的关键信息和促进理解的内容”的指南草案。该指南就美国卫生与公众服务部（HHS）修订的《联邦...
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards 2024年3月1日,FDA发布了一份题为“申办方、研究者和机构审查委员会知情同意指南中的关键信息和促进理解的内容”的指南草案。该指南就美国卫生与公众服务部(HHS)修订的《联邦人类...
approved uses raise the question of what pa- tients subjected to these products should be told as part of the informed consent process. FDA Medical Device Regulation Current FDA regulation of medical devices is based on the Food, Drug, and Cosmetic Act (FDCA) as modified by the Medical ...