美国食品药物管理总局(FOOD AND DRUG ADMINISTRATION,简称 FDA)情况简介

FDA是美联邦政府卫生部(DEPARTMENT OF HEALTH AND HUMAN SERVICE简称DHHS直译应为卫生及人类服务部,实即卫生部及有关福利事宜)下的直属机构。是对食品及药物等方面制定规范及进行管理的权威性机关。FDA除主要对食品、药物外还包括有生物制品,化妆品及医疗设施等的管理,与农业部(负责肉类、疏菜、水果的管理)、环境保护局(E.P.A)(负责空气、饮水、废弃物、农药、毒品等的管理)分工统管环境中的化学物。它们都是以立法为根据的代表政府的执法机关。 FDA的前身为化学部(DEPARTMENT OF CHEMLSTRY)建于1906年。现有工作人员约8。

Work Hard to Ensure Food,Drugs Safety for the People——An interview with Shao Mingli,director-general of the State Food and Drug Administration(SFDA)

Following is an interview given by Shao Mingli, director-general of China＇s State Food and Drug Administration to our reporter on what is being done to ensure food and drug safety in China. As everybody knows, food and drug safety is vital to people＇s lives.

The State Food and Drug Administration:Supervisory Regulations on Cosmetics May Be Introduced This Year

On May 28, 2019 Chinese Cosmetics Development Conference was held in Beijing. At the conference, Li Nan, chief of the General Division, Supervision Department of the State Food and Drug Administration introduced China’s development concerning the cosmetics supervisory rules and regulations from the perspectives of legislation plan and thinking. He mentioned that the regulations on supervision and administration of cosmetics are expected to be released this year, and the regulations on cosmetic registration and label management.

Repurposing Loperamide as an Anti-Infection Drug for the Treatment of Intracellular Bacterial Pathogens

Infections caused by intracellular bacterial pathogens are difficult to treat since most antibiotics have low cell permeability and undergo rapid degradation within cells.The rapid development and dissemination of antimicrobial–resistant strains have exacerbated this dilemma.With the increasing knowledge of host–pathogen interactions,especially bacterial strategies for survival and proliferation within host cells,host-directed therapy(HDT)has attracted increased interest and has emerged as a promising antiinfection method for treating intracellular infection.Herein,we applied a cell-based screening approach to a US Food and Drug Administration(FDA)-approved drug library to identify compounds that can inhibit the intracellular replication of Salmonella Typhimurium(S.Typhimurium).This screening allowed us to identify the antidiarrheal agent loperamide(LPD)as a potent inhibitor of S.Typhimurium intracellular proliferation.LPD treatment of infected cells markedly promoted the host autophagic response and lysosomal activity.A mechanistic study revealed that the increase in host autophagy and elimination of intracellular bacteria were dependent on the high expression of glycoprotein nonmetastatic melanoma protein B(GPNMB)induced by LPD.In addition,LPD treatment effectively protected against S.Typhimurium infection in Galleria mellonella and mouse models.Thus,our study suggested that LPD may be useful for the treatment of diseases caused by intracellular bacterial pathogens.Moreover,LPD may serve as a promising lead compound for the development of anti-infection drugs based on the HDT strategy.

美国FDA致幻药临床研究考虑要点的行业指导原则草案介绍

目的:促进我国对致幻药精神心理疾病治疗应用的开发、研究和监管。方法:在美国食品药品管理局(FDA)网站,查寻新近发布的相关指导原则并详细而具体地介绍该指导原则。结果与结论:展示了FDA于2023年6月发布的“致幻药临床研究考虑要点的行业指导原则草案”的具体内容,为开发用于治疗精神心理疾病(例如精神障碍、物质使用障碍)的致幻药提出了一些临床研究的一般考虑因素,以确保符合伦理要求以及试验完整性和结果可靠性。指导原则按专业领域分别讨论了致幻药与临床研究相关的化学、生产和控制;非临床试验;临床药理学;滥用可能性评估和临床试验方面面临的特殊问题。该指导原则对我国开展这方面的工作具有重要参考价值。

Anti-obesity drugs currently used and new compounds in clinical development

Obesity is a chronic disease which requires treatment. As lifestyle interventions alone hardly ever result in long-term weight loss, pharmacotherapy is an impor-tant adjunct to lifestyle measures to improve the induc-tion and maintenance of weight loss. Owing to the lim-ited options currently available for the pharmacological treatment of obesity, it is imperative to develop new safe compounds. This study aims to review the current medications approved by European Medicines Agency and United States Food and Drug Administration （FDA） for the treatment of obesity, focusing essentially on their benefits and risks, as well as on the new drugs which are presently under clinical trials. Moreover, it lists the anti-obesity agents that have been recently withdrawn from the market. A revision of the scientifc literature was carried out, through a search on Pubmedfor papers published from January 2010 to January2013. Orlistat （Xenical？） is currently the only long-termpharmacotherapy for obesity available in the Europeanmarket, as rimonabant and sibutramine were with-drawn in 2008 and 2010, respectively, due to serious psychiatric and cardiovascular adverse effects. Lorca-serin （Belviq？） and the association of phentermine and topiramate （QsymiaTM） were recently approved by FDA. Orlistat suppresses appetite inhibiting gastrointestinal lipase, being its adverse effects mostly gastrointestinal. Lorcaserin activates 5-HT2C receptors, phentermine is a norepinephrine releasing drug, and topiramate is an anticonvulsivant drug with weight loss properties.

Modes of failure with fractional flow reserve guidewires:Insights from the manufacturer and user facility device experience database

BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.

基于openFDA对罗莫珠单抗不良反应风险信号的挖掘与分析

目的对新型抗骨质疏松药物罗莫珠单抗相关不良反应进行分析及风险信号挖掘,为临床用药安全性提供参考依据。方法借助美国食品药品监督管理局公共数据开放项目,调取2014年1月1日-2022年9月10日美国食品药品监督管理局不良事件报告系统收到的罗莫珠单抗的不良事件报告,应用国际医学用语词典v24.0的首选系统器官分类和首选术语对不良事件进行分类。采用报告比值比法,对报告数排名前50位的不良事件进行不良反应信号挖掘。结果检索出不良事件报告共11118925份,其中与罗莫珠单抗相关的报告为4375份,报告主要来自日本和美国,患者75.5%为女性,患者年龄主要分布于60~89岁。在报告数排名前50的不良事件中,共检测出32个阳性信号,包括代谢及营养类疾病3个,各类检查2个,各类损伤、中毒及操作并发症1个,各种手术及医疗操作1个,肌肉骨骼及结缔组织疾病9个,泌尿及肾脏系统疾病1个,全身性疾病及给药部位各种反应8个,神经系统疾病2个及心脏器官疾病5个。其中,肾脏损害为说明书未提及的不良反应。结论临床应关注罗莫珠单抗潜在的不良反应,尤其警惕其相关心血管不良事件、过敏或超敏反应、低钙血症、下颌骨坏死、非典型性股骨骨折及肾脏损害。对于说明书未提及的罗莫珠单抗相关肾脏损害,应给予足够重视及进一步的探究。

SGLT2抑制剂的生殖毒性:基于美国FDA不良事件报告系统的信号挖掘与分析

目的利用美国FDA不良事件报告系统(FAERS)对钠-葡萄糖共转运蛋白2(SGLT2)抑制剂的生殖系统药物毒性进行全面分析,挖掘潜在的生殖系统不良事件信号,以期为临床合理用药提供参考。方法采用压缩估计的不相称测定分析,选取报告比值比法(ROR)和成分信息法(IC)对FAERS中2013年第1季度至2021年第2季度有关SGLT2抑制剂的数据进行挖掘,借助重要医疗事件(IME)列表筛选出生殖系统IME。所有的不良事件及IME均由《国际医学用语词典》(MedDRA)24.0版编码。分析患者的临床特征、预后、信号检测结果及指定不良事件的事件发生时间(TTO)。结果将SGLT2抑制剂作为“首要怀疑”和“次要怀疑”的生殖系统不良事件报告纳入分析,共获得2700条记录。男性生殖系统不良事件发生频率(57.59%,1555/2700)高于女性(35.70%,964/2700),单药治疗与生殖不良事件的关联强度高于联合用药(IC的95%CI下限:1.40 vs 1.21;ROR的95%CI下限:2.65 vs 2.37)。在单药治疗中共检测出56个信号,出现8个强信号和13个IME。常见的生殖系统不良事件是Fournier坏疽、生殖器真菌感染、龟头包皮炎等。说明书中未提及的IME共10个,包括男性外生殖器蜂窝织炎、乳腺癌、阴茎癌等。结论除了已知的生殖系统不良事件,SGLT2抑制剂还存在其他重要的生殖系统不良事件信号。不同SGLT2抑制剂的生殖毒性存在差异性,临床医师应充分考量用药的风险与收益,对严重不良事件进行重点监测。

Microbiological Quality of Freshly Prepared, Packaged Fruit and Milk Juices Sold in Cafés, Shops, and Supermarkets in Hargeisa, Somaliland

Background: Due to their delicious taste, high nutritional content, and health benefits, fruit juices are well-known drinks in many countries and are now an essential component of the modern diet. Objective: Determining the microbiological quality of both packaged and freshly made fruit and milk juices. Method: The spread-plate approach was employed to isolate and count the bacteria. 90 ml of sterile peptone water were blended with 10 ml of well-mixed, packed, and freshly made fruit juices. The samples were sequentially diluted (101 - 105) in accordance with the Indian Manual of Food Microbiological Testing Methods. Results: From eight samples of imported packaged fruit and milk juice, the average of total coliform, staphylococci, and viable bacterial counts were zero, 1.39 × 102, and 2 × 102 CFU/ml, respectively. In contrast, from three samples of locally produced fruit and milk juice, the average of total coliform, staphylococci, and viable bacterial counts were zero, 5.83 × 102, and 2.73 × 103 CFU/ml, respectively. Four samples of handmade prepared fruit and milk juices had a mean of total coliform, staphylococci, and viable bacterial count of 1.441 × 104, 4.1 × 103, and 2.35 × 105 CFU/ml, respectively. Conclusion: 33.3% of the results from microbiological analysis of freshly made fruit and milk juices met the permissible range of the Revised Microbiological Standards for Fruit and Vegetables and Their Products, which were published in 2018 and as well as the Hong Kong Center for Food Safety, whereas 66.7% of the microbiological analyses of freshly prepared fruit and milk juices were above the permissible reference range of GSO standard 2000. 12.5% of the investigated imported and packed fruits and milk juices had one failed test (TSC), which was above the acceptable limit, 87.5% of the tested samples of fruit and milk juices fulfilled the necessary standards of TCC, TVBC, and TSC. 100% of the tested locally manufactured fruit and milk juices complied with TSC, TCC, and TVBC requirements. All investigations showed that freshly made fruit and milk juices were heavily contaminated (Total viable bacterial count, total coliform count, and total staphylococcus count). .

“万络撤市事件”后美国FDA药品安全监管体系的变革和具体应对举措分析

本文梳理了美国FDA“万络撤市事件”的时间线,通过回顾万络不良反应证据在不同阶段的累积过程,并利用Meta数据挖掘手段在相应阶段进行动态分析,评估如何及发现万络存在严重心肌梗死风险,进一步剖析美国FDA在“万络撤市事件”中监管滞后的原因(包括信息采集来源单一、信号挖掘与分析能力不足、风险评估与决策过程中沟通不畅等)。本文通过总结“万络撤市事件”发生后美国FDA药品安全监管体系的变革和具体应对举措(包括颁布新的法案、重组机构、开展监管科学研究等),以期从法律体系、组织体系、技术体系等方面进一步为我国药品上市后安全性监测模式的完善提供参考和建议。

Status quo of resource allocation of Chinese grass-roots food and drug administrations: from 2011 to 2016

County grass-root food and drug administrations （CGFDA） undertake the front-line supervision of food and drug safety, whose resource allocation is vital to the regulation efficiency and performance. In this article, we aimed to analyze the status quo of resource allocation of CGFDA from the aspects of regulatory organization, staff, funding and equipment using official panel data from 2011 to 2016. The results illustrated that the total amount of regulatory resources of CGFDA was increased annuall y, reaching a rather large scale. However, many problems still existed in its allocation. Therefore, a series of measures should be taken to optimize the resource allocation of CGFDA, such as improving the network of institutional CGFDA, increasing the recruitment requirements on educational level and major, reallocating the structure of resources and guaranteeing the resource demand in less-developed areas.

美国FDA的食品监管机构和管理措施简介

本文主要介绍了美国FDA食品安全及营养中心的机构建制、主要管理领域及管理措施 ,从而为我国的食品、化妆品监管提供可借鉴的信息。

美国FDA药物短缺应对策略及其对我国的启示

通过介绍美国食品药品监督管理局(FDA)应对药物短缺的机构设置、法规制定和提高自由裁量权,以期为我国提供借鉴,最终改善药物短缺状态,提高药物可及性,保障用药需求,促进我国医疗卫生事业的发展。

2014年美国FDA批准的新药分析

目的:对2014年美国FDA批准的新药进行分析,供医药界和相关管理部门参考。方法:查阅Drugs@FDA数据库,收集2014年FDA批准的新药信息,进行统计分析。结果与结论:2014年FDA共批准41个新药,是自1997年以来的最高数量,其中新药申请(新分子实体)30个、生物制品许可申请11个。批准的新药中获得优先审查、突破性治疗、加速审批和快速通道资格的分别为25个、9个、8个和17个(有的新药获得一种以上优先资格),认定孤儿药的为17个。批准新药的治疗领域以抗微生物药(皮肤及皮肤组织感染、基因1型丙肝感染和趾甲真菌感染等)、抗肿瘤药(淋巴瘤、黑色素瘤等)和代谢系统用药(2型糖尿病等)为主,剂型以注射剂、片剂和胶囊剂为主。

美国openFDA数据公开对我国食品药品监管数据管理的启示

目的:分析美国食品药品管理局(FDA)公共数据开放项目(openFDA)的启动背景、运行模式和管理经验,为我国食品药品监管数据管理工作提供参考。方法:采用文献研究的方法,对FDA政府网站有关专栏和openFDA项目网站以及在中国知网等数据库中检索到的文献资料进行分析研究。结果与结论:openFDA项目自开展以来积累了大量数据,采取提供应用程序接口、提供数据资料直接下载,以及建立开发者社区为其提供交流和分享的平台多种方式进行公共数据开放,并已取得了一定成效,值得思考借鉴。

美国FDA食品安全现代化法案解读与评析

对美国2011年初出台的《FDA食品安全现代化法案》进行了解读和评析,介绍了该法案的修法背景、立法目的和适用范围,以及对现行食品安全法律《联邦食品药品化妆品法》的主要修改和新设立的法律制度与措施,分析了美国进口食品安全监管新举措对我国输美食品生产企业和相关行业的影响。建议密切跟踪FDA食品安全现代化法案的实施情况和配套法规的制定进程,深入研究并积极应对美国第三方审核认可制度,系统评估美国进口食品安全监管新举措对我国可能造成的影响,学习借鉴美国现代化食品的安全监管理念和科学的法律制度设计。

美国FDA哨点行动及其对我国食品药品监管数据管理的启示

目的:介绍美国FDA哨点行动背景、项目、内容、特点,为我国食品药品监管数据共享利用和管理提供参考。方法:使用文献研究的方法,围绕美国食品药品管理局哨点行动计划收集材料并梳理分析。结果与结论:信息化和大数据时代背景下数据资源共享与食品药品监管业务工作密不可分;顶层支持有助于数据协同共享等工作开展;分布式数据管理模式值得借鉴;产学研结合有助于开展数据分析挖掘;相关方广泛参与有助于从源头保障数据质量。

美国FDA有效实施医疗器械唯一标识(UDI)系统的经验启示

医疗器械唯一标识(unique device identifier,UDI)是医疗器械唯一性识别码,是准确采集医疗器械全生命周期数据的基础,已成为当前医疗器械监管的全球通用语言。2013年9月24日,美国食品药品管理局(Food and Drug Administratio,FDA)发布医疗器械唯一标识系统(unique device identification system,UDI system)最终规定并正式实施UDI,为各国以全球协调方式实施UDI提供了经验。本文将系统研究美国UDI发展沿革、法规体系、核心内容与工作进展,对美国UDI实施方案、发码机构、全球UDI数据库(GUDID)及应用情况进行介绍,为我国开展并推进UDI工作提供借鉴和思路。

FDA药品准入监管及其后果——对中国食品安全标准立法的启示

美国FDA对药品的严格准入监管提高了上市药品的安全性,但也抬高了药品价格,遏制了市场竞争,阻碍了药品研发,延误了危重病人的治疗。汲取FDA监管的教训,中国在制定食品安全标准立法时,不应单纯追求过高的安全标准,而应综合衡量特定食品安全标准的社会收益和社会成本。中国食品安全监管应采取信息披露监管和强制标准相结合,即以促进信息披露为主要制度基础,着重保障消费者的知情权和选择权。同时,在企业和消费者对食品品质进行判断的信息不足、食品安全潜在危害后果重大等情况下,则应由政府实施强制性安全标准。