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.

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 important adjunct to lifestyle measures to improve the induction and maintenance of weight loss.Owing to the limited 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new drugs which are presently under clinical trials.Moreover,it lists the anti-obesity agents that have been recently withdrawn from the market.A revision of the scientific literature was carried out,through a search on Pubmed for papers published from January 2010 to January2013.Orlistat(Xenical) is currently the only long-term pharmacotherapy for obesity available in the European market,as rimonabant and sibutramine were with-drawn in 2008 and 2010,respectively,due to serious psychiatric and cardiovascular adverse effects.Lorcaserin(BelviqTM) and the association of phentermine and topiramate(Qsymia TM) were recently approved by FDA.Orlistat suppresses appetite inhibiting gastrointestinal lipase,being its adverse effects mostly gastrointestinal.Lorcaserin activates 5-HT2 C 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.

TCM-based new drug discovery and development in China

Over the past 30 years, China has significantly improved the drug development environment by establishing a series of policies for the regulation of new drug approval. The regulatory system for new drug evaluation and registration in China was gradually developed in accordance with international standards. The approval and registration of TCM in China became as strict as those of chemical drugs and biological products. In this review, TCM-based new drug discovery and development are introduced according to the TCM classification of nine categories.

Analysis of the adverse reactions of atezolizumab: A real-world study based on FAERS database

Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.

Status and Thoughts of Chinese Patent Medicines Seekina Annroval in the US Market

Veregen^TM and Fulyzaq are the first two botanical drug products that were approved by the Food and Drug Administration （FDA） to market in the US in recent years. Additional herbal medicines, including Compound Danshen Dripping Pills （复方丹参滴丸）, Fuzheng Huayu Tablets （扶正化瘀片）, Xuezhikang Capsule （血脂康胶囊）, Guizhi Fuling Capsule （桂枝茯苓胶囊）, Kanglaite Capsule （康莱特胶囊） and Kanglaite Injection （康莱特注射液）, have filed the investigational new drug （IND） application to the FDA and are in phaseⅡ or phase Ⅲ clinical development. In order to gain better understanding of the process of botanical drug approval in the US, this article examines the aforementioned drugs by looking at their composition, indication, prior clinical experience and clinical development process, and summarizes key features that enabled IND filing and marketing approval by the FDA.

Adipose-derived cells:building blocks of three-dimensional microphysiological systems

Microphysiological systems(MPS)created with human-derived cells and biomaterial scaffolds offer a potential in vitro alternative to in vivo animal models.The adoption of three-dimensional MPS models has economic,ethical,regulatory,and scientific implications for the fields of regenerative medicine,metabolism/obesity,oncology,and pharmaceutical drug discovery.Key opinion leaders acknowledge that MPS tools are uniquely positioned to aid in the objective to reduce,refine,and eventually replace animal experimentation while improving the accuracy of the finding’s clinical translation.Adipose tissue has proven to be an accessible and available source of human-derived stromal vascular fraction(SVF)cells,a heterogeneous population available at point of care,and adipose-derived stromal/stem cells,a relatively homogeneous population requiring plastic adherence and culture expansion of the SVF cells.The adipose-derived stromal/stem cells or SVF cells,in combination with human tissue or synthetic biomaterial scaffolds,can be maintained for extended culture periods as three-dimensional MPS models under angiogenic,stromal,adipogenic,or osteogenic conditions.This review highlights recent literature relating to the versatile use of adipose-derived cells as fundamental components of three-dimensional MPS models for discovery research and development.In this context,it compares the merits and limitations of the adipose-derived stromal/stem cells relative to SVF cell models and considers the likely directions that this emerging field of scientific discovery will take in the near future.

Drug flibanserin–in hypoactive sexual desire disorder

Hypoactive sexual desire disorder(HSDD)is a widely known type of female sexual dysfunction that could also cause emotional distress and relationship problems.Flibanserin,a benzimidazole,was being studied as a treatment for premenopausal women with hypoactive sexual desire disorder because there was no accurate drug therapy available at the time(HSDD).The US Food and Drug Administration(FDA)approved Flibanserin in 2015 for the treatment of generalised acquired HSDD in premenopausal women.It has a high affinity for postsynaptic 5-HT-1A receptors(agonist)and 5-HT-2A receptors(antagonist),and it tends to work by increasing dopamine and noradrenaline levels in the brain while decreasing serotonin levels.This review was to assess Flibanserin efficacy and safety and it is found the drug Flibanserin benefits did not outweigh the risks in premenopausal and postmenopausal women.