美国食品和药物管理局（FDA）组织机构、基本职责及所执行的法律

本文介绍了美国食品和药物管理局(FDA)的基本职责、组织机构及其所执行的法律的概况。     

美国FDA对进口医疗器械产品的要求及应对措施

介绍了美国食品和药物管理局(FDA)对医疗器械产品的要求和规定,包括医疗器械的上市前管理要求和上市后的监管规定。并提出了促进我国医疗器械产品出口的建议。     

关于购置进口医学仪器的程序问题

进口医学仪器的购置,涉及的金额大、周期长、环节多,需多部门协同运作。如果缺乏对购置程序的总体了解,就无法合理安排、协调各环节,甚至会因一些小的疏漏,给单位造成巨大经济损失,严重影响医疗、科研工作的如期进展。     

关于购置进口医学仪器的程序问题

进口医学仪器的购置中,涉及的金额大,周期长,环节多,需多部门协同运作,若缺乏对购置程序的总体了解,就无法运用运筹学的方法合理安排、协调各项环节,甚至会因一些小的疏漏,给单位造成巨大经济损失,严重影响医疗、科研工作的如期进展。实践过程中,我们总结出了进口仪器的购置流程。     

美国FDA发布美敦力（Medtronic）公司的召回通告

产品：Octopus Nuvo组织固定器。 召回范围：型号为TSMICS1;批号为201002P030, 2010030795,2010032195,2010032196,2010032690, 2010033377,2010040102,2010040103,2010040673, 2010041001,2010041500,2010061786,2010062722, 2010071111,2010081105,2010081987等的产品。     

国家药监局印发医疗器械注册复审程序（试行）的通知

日前,国家局组织制定并印发了《医疗器械注册复审程序（试行）》,适用于境内、进口医疗器械（含体外诊断试剂）首次注册、重新注册、注册证书变更的退审或不予注册（含不予变更）审批决定的复审申请。食品药品监督管理部门受理复审申请后,应当按照原注册审评审批程序,对复审项目进行复审。     

身心语法程序和团体辅导改善孕产妇心理状况的对照研究

妊娠期妇女身心健康除了妊娠本身对孕产妇的影响外,一些不利的社会因素也会引起孕产妇紧张、抑郁和焦虑等负性情绪与心理状态[1]。怀孕期间孕产妇过度的焦虑或抑郁与某些妊娠并发症的发生有密切关系,如:妊高征、早产、胎儿窘迫、难产、产后出血和剖宫产等[2]。但是     

某军医大学进口仪器设备的采购与引进

进口仪器设备的引进是确保军医大学医疗、教学、科研工作有效运转的保证。引进仪器设备的程序比较繁杂，办理机电产品进口登记证和申请减免税的手续政策性很强，预防和减少各个环节的纰漏，保证及时顺利地引进仪器设备，是仪器设备主管部门需要引起重视的问题。本文旨在梳理仪器设备引进的程序，把握好政策，保障教医研工作的顺利开展。     

涉水产品浸泡液中铬（六价）测定方法的探讨

目的:探讨涉水产品浸泡液中铬(六价)的测定方法,提高分析结果的准确性.方法:在酸性条件下,用尿素(200 g/L)消除浸泡液中氯的干扰,用二苯碳酰二肼分光光度法测定.结果:铬(六价)在0～50μg/L范围内线性良好,相关系数0.9994,最低检测质量浓度为0.004 mg/L,回收率为93.3%～98.2%;重复测定某一涉水产品浸泡液中铬(六价)8次,s=0.5012,相对标准偏差为3.39%.结论:可适用于涉水产品浸泡液中铬(六价)的测定.     

美国FDA设备和辐射卫生中心2006财政年度报告（三）（2005年10.1-2006年9.30）

为了确保医疗器械和辐射性器械的安全和有效，CDRH制定和颁布了良好制造规范要求；对上市产品监控其顺应性和监督项目；对产品的不良效果报告进行收集、分析和采取行动。中心的目标是提高检查，报告，实施行动的优先、协作、一致，以保证上市产品持续的安全和有效。     

美国FDA新草案对中医药发展的影响

传统医药市场需求的不断扩大，已经引起全世界越来越多人们的关注和接受。美国食品药品管理局（FDA）新发布的《补充和替代医学产品及FDA管理指南》草案，标志着美国FDA对其他国家传统医药的认识和管理发生了变化。这不仅为我国中医药产品进入美国市场创造了有利条件，而且对我国中医药的国际化进程将产生积极的影响。     

美国食品与药物管理局对于进口到美国的医疗设备的要求

医疗设备的外国制造商想要在美国销售其产品，除了遵从美国海关及边防保护局的进口规定之外．也必须遵从美国食品与药物管理局（FDA）的进口规定。这些规定包括工厂的注册，医疗设备清单，质量系统，医疗设备报告，售前批准或者认可，商标及美国代理的要求。在试图进口医疗设备到美国之前，了解应用于你们公司及其医疗设备的规定，并依次地按照步骤去遵从这些规定．是你们成功的关键。这篇文章简要地介绍了FDA对制造商进口医疗设备到美国的规定并提供了准备设备进口的建议。     

US Food and Drug Administration documents can provide unpublished evidence relevant to systematic reviews

ObjectivesA key systematic review (SR) methodology is comprehensive searching. The Drug Effectiveness Review Project (DERP) SRs search US Food and Drug Administration (FDA) documents to identify unpublished evidence. This study evaluates the success of those efforts.Study Design and SettingWe examined DERP reports published since 2003 for the use of FDA preapproval and postmarketing documents. We categorized evidence as (1) unique unpublished studies, (2) supplemental unpublished data, or (3) FDA postmarketing data analysis. Three reviewers independently assigned predetermined impact categories (e.g., qualitative or quantitative usage, fills gaps, confirms findings, and alters conclusions), resolving disagreements through consensus.ResultsAmong 114 DERP reports, 19% included unpublished studies and/or supplemental data and 10% included postmarketing analyses. From 175 preapproval documents, 14% provided eligible unpublished studies and 4.0% supplemental unpublished data that helped confirm previous findings, identify important harms, and fill gaps in knowledge about understudied subpopulations, outcomes, and comparisons. Report conclusion statements changed in 9 of 33 instances of premarketing documents compared with 4 of 12 postmarketing analyses.ConclusionsThe FDA documents can provide important unpublished evidence for SRs, although in a small proportion of cases. Future research should identify attributes that predict which reviews may benefit most from review of FDA documents.     

Perception of the Food and Drug Administration Electronic Cigarette Flavor Enforcement Policy on Twitter: Observational Study

BackgroundOn January 2, 2020, the US Food and Drug Administration (FDA) released the electronic cigarette (e-cigarette) flavor enforcement policy to prohibit the sale of all flavored cartridge–based e-cigarettes, except for menthol and tobacco flavors.ObjectiveThis research aimed to examine the public perception of this FDA flavor enforcement policy and its impact on the public perception of e-cigarettes on Twitter.MethodsA total of 2,341,660 e-cigarette–related tweets and 190,490 FDA flavor enforcement policy–related tweets in the United States were collected from Twitter before (between June 13 and August 22, 2019) and after (between January 2 and March 30, 2020) the announcement of the FDA flavor enforcement policy. Sentiment analysis was conducted to detect the changes in the public perceptions of the policy and e-cigarettes on Twitter. Topic modeling was used for finding frequently discussed topics about e-cigarettes.ResultsThe proportion of negative sentiment tweets about e-cigarettes significantly increased after the announcement of the FDA flavor enforcement policy compared with before the announcement of the policy. In contrast, the overall sentiment toward the FDA flavor enforcement policy became less negative. The FDA flavor enforcement policy was the most popular topic associated with e-cigarettes after the announcement of the FDA flavor enforcement policy. Twitter users who discussed about e-cigarettes started to talk about other alternative ways of getting e-cigarettes after the FDA flavor enforcement policy.ConclusionsTwitter users’ perceptions of e-cigarettes became more negative after the announcement of the FDA flavor enforcement policy.     

Roxarsone,Inorganic Arsenic,and Other Arsenic Species in Chicken: A U.S.-Based Market Basket Sample

Background: Inorganic arsenic (iAs) causes cancer and possibly other adverse health outcomes. Arsenic-based drugs are permitted in poultry production; however, the contribution of chicken consumption to iAs intake is unknown.Objectives: We sought to characterize the arsenic species profile in chicken meat and estimate bladder and lung cancer risk associated with consuming chicken produced with arsenic-based drugs.Methods: Conventional, antibiotic-free, and organic chicken samples were collected from grocery stores in 10 U.S. metropolitan areas from December 2010 through June 2011. We tested 116 raw and 142 cooked chicken samples for total arsenic, and we determined arsenic species in 65 raw and 78 cooked samples that contained total arsenic at ≥ 10 µg/kg dry weight.Results: The geometric mean (GM) of total arsenic in cooked chicken meat samples was 3.0 µg/kg (95% CI: 2.5, 3.6). Among the 78 cooked samples that were speciated, iAs concentrations were higher in conventional samples (GM = 1.8 µg/kg; 95% CI: 1.4, 2.3) than in antibiotic-free (GM = 0.7 µg/kg; 95% CI: 0.5, 1.0) or organic (GM = 0.6 µg/kg; 95% CI: 0.5, 0.8) samples. Roxarsone was detected in 20 of 40 conventional samples, 1 of 13 antibiotic-free samples, and none of the 25 organic samples. iAs concentrations in roxarsone-positive samples (GM = 2.3 µg/kg; 95% CI: 1.7, 3.1) were significantly higher than those in roxarsone-negative samples (GM = 0.8 µg/kg; 95% CI: 0.7, 1.0). Cooking increased iAs and decreased roxarsone concentrations. We estimated that consumers of conventional chicken would ingest an additional 0.11 µg/day iAs (in an 82-g serving) compared with consumers of organic chicken. Assuming lifetime exposure and a proposed cancer slope factor of 25.7 per milligram per kilogram of body weight per day, this increase in arsenic exposure could result in 3.7 additional lifetime bladder and lung cancer cases per 100,000 exposed persons.Conclusions: Conventional chicken meat had higher iAs concentrations than did conventional antibiotic-free and organic chicken meat samples. Cessation of arsenical drug use could reduce exposure and the burden of arsenic-related disease in chicken consumers.     

美军联合医疗分析工具介绍及分析

联合医疗分析工具（JMAT）的前身是医疗分析工具（MAT）。该工具是美国参谋长联席会议和国防部批准授权应用的卫勤规划模拟工具。美军2001版和2006版《联合作战卫勤保障》条令中将医疗分析工具作为联合作战卫勤保障计划制定的重要参考。联合医疗分析工具是一种基于Windows操作系统的卫勤模拟工具,医疗计划人员用该工具来确定战区医疗保障需求。本文介绍美军联合医疗分析工具的概况、开发和运行、信息输入、数据输出,并对模型进行分析评价。