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Revising the Regulation of Stem Cell-Based Therapies: Critical Assessment of Potential Models. 修改干细胞疗法的规则:对潜在模型的关键评估。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2015-01-01
Barbara von Tigerstrom

The regulation of stem cell-based therapies is challenging in many respects, given their unique safety, efficacy, and quality issues. At the same time, public interest in these innovative therapies has led some to question FDA's regulation of them, while others urge strict regulation and stronger enforcement. Within the context of this broader debate, this article examines recent attempts in other jurisdictions to craft specific provisions allowing additional flexibility in regulating cell and tissue therapies: Australia's exemption for autologous cell and tissue therapies, and the hospital exemption in Europe's regulation for advanced therapies.

鉴于干细胞疗法独特的安全性、有效性和质量问题,其监管在许多方面都具有挑战性。与此同时,公众对这些创新疗法的兴趣导致一些人质疑FDA对它们的监管,而另一些人则敦促严格监管和加强执法。在这一广泛辩论的背景下,本文考察了其他司法管辖区最近为制定允许在调节细胞和组织疗法方面具有额外灵活性的具体条款所做的尝试:澳大利亚对自体细胞和组织疗法的豁免,以及欧洲对先进疗法的医院豁免。
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引用次数: 0
Can You Diagnose Me Now? A Proposal to Modify FDA's Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database System. 你现在能诊断我吗?通过上市前通知和应用程序数据库系统修改FDA智能手机移动健康应用程序法规的建议。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2015-01-01
Stephen McInerney

Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) has the authority to regulate a much broader spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if FDA has the statutory. authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, FDA published guidance on Mobile Medical Applications; in it, the Agency limited its oversight to a small subset of medical-related mobile applications, referred to as "mobile medical applications." For the guidance to be effective, FDA must continue to work directly with all actors--including innovators, doctors, and patients--as the market for mobile health applications continues to develop. This Article argues that FDA should adopt a two-step plan--a pre-market notification program and a mobile medical application database--to aid in the successful implementation of its 2013 guidance. By doing so, FDA will ensure that this burgeoning market can reach its fullest potential.

移动应用程序为未来的医疗保健提供了无限的可能性。然而,这些变化也引发了对患者安全的担忧。根据《联邦食品、药品和化妆品法案》(FDCA),美国食品和药物管理局(FDA)有权监管比听诊器或起搏器等传统医疗设备更广泛的产品。监管问题不在于FDA是否有法律规定。管理与健康相关的软件的权力,而是如何行使其监管权力。2013年9月,FDA发布了移动医疗应用指南;在其中,该机构将其监管范围限制在一小部分与医疗相关的移动应用程序,称为“移动医疗应用程序”。为了使指南有效,随着移动医疗应用市场的不断发展,FDA必须继续与所有参与者(包括创新者、医生和患者)直接合作。本文认为,FDA应采取两步计划——上市前通知程序和移动医疗应用数据库——以帮助成功实施其2013年指南。通过这样做,FDA将确保这个新兴市场能够充分发挥其潜力。
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引用次数: 0
"Bringing a Butter Knife to a Gun Fight"? Salience, Disclosure, and FDA's Differing Approaches to the Tobacco Use and Obesity Epidemics. "带着黄油刀去打枪战"?烟草使用和肥胖症流行的显著性、信息披露和 FDA 的不同方法。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2015-01-01
Josef Weimholt

One might expect--given the vastly different look, feel, and function of the ubiquitous (and innocuous) Nutrition Facts panel and the "inflammatory" graphic warning labels for cigarettes--that the statutes establishing such disclosure requirements would exhibit similar disparities. In fact, the relevant provisions of the Nutrition Labeling and Education Act of 1990 and the Family Smoking Prevention and Tobacco Control Act of 2009 are. quite analogous. Like other mandated disclosures, the nutrition label and the cigarette. graphic warnings seek to simultaneously inform and influence consumer decisions. Both statutes grant FDA considerable discretion in.the implementation of the labeling requirements, generally allowing the agency to alter the format and content of the labels as necessary to promote the statutory goals. Thus, the differences in the nutrition and cigarette warning labels are not the product of the statutory schemes alone; rather, they reflect important differences in FDA's interpretation and prioritization of the dual regulatory goals, and in the agency's implicit or explicit assumptions about human behavior.

考虑到无处不在的(无害的)营养信息面板和香烟的 "煽动性 "图形警告标签在外观、感觉和功能上的巨大差异,人们可能会认为,制定此类披露要求的法规也会表现出类似的差异。事实上,1990 年的《营养标签和教育法》和 2009 年的《家庭吸烟预防和烟草控制法》的相关规定非常相似。与其他强制披露的信息一样,营养标签和香烟图形警示试图同时告知和影响消费者的决定。这两项法规在实施标签要求时都赋予了食品药品管理局相当大的自由裁量权,通常允许该局在必要时改变标签的格式和内容,以促进实现法定目标。因此,营养标签和香烟警示标签的不同并不仅仅是法定方案的产物;相反,它们反映了食品和药物管理局对双重监管目标的解释和优先顺序的重要差异,以及该机构对人类行为的隐含或明确假设。
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引用次数: 0
Drugs, Devices & Discovery: Using Fee-Shifting to Resolve the Twombly/Iqbal Problem for Parallel Claims Under the FDCA. 药物,器械和发现:使用费用转移来解决FDCA下平行索赔的Twombly/Iqbal问题。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2015-01-01
Cameron T Norris

The Supreme Court's decisions in Twombly and Iqbal ushered in a new federal pleading standard, requiring plaintiffs to state a "plausible" claim to relief before they can access discovery. Plausibility pleading, however, presents a unique burden for plaintiffs who have been injured by a Class III medical device. In Riegel, the Supreme Court held that state-law claims against device manufacturers are preempted unless they "parallel" federal requirements. However, the relevant federal requirements are located in the manufacturer's premarket approval agreement, which is confidential. Thus, it is nearly impossible for plaintiffs to allege a plausible claim against a Class III device manufacturer because they do not know what to plead in the first place. The Seventh Circuit tried to remedy this Catch-22 by lowering the pleading standards for parallel claims. However, its approach misapplies Twombly and Iqbal and overburdens device manufacturers. Instead of tinkering with pleading standards, this paper advocates a different approach. Congress should create a one-way fee-shifting mechanism that allows plaintiffs to access premarket approval agreements if they agree to pay the defendant's discovery fees (should their claim prove unsuccessful). Fee-shifting is a middle-ground approach that would better compensate plaintiffs without overdeterring device manufacturers.

最高法院在托姆布雷案和伊克巴尔案中的裁决开创了一种新的联邦辩护标准,要求原告在获得证据开示之前陈述一个“合理的”救济要求。然而,对于被第三类医疗器械伤害的原告来说,合理性抗辩是一种独特的负担。在Riegel案中,最高法院认为,除非与联邦要求“平行”,否则州法律对设备制造商的索赔是优先的。然而,相关的联邦要求位于制造商的上市前批准协议中,这是保密的。因此,原告几乎不可能对III类器械制造商提出合理的索赔,因为他们首先不知道该为什么辩护。第七巡回法院试图通过降低平行诉讼的辩护标准来纠正这一困境。然而,它的方法误用了Twombly和Iqbal,给设备制造商带来了过重的负担。本文提倡一种不同的方法,而不是对辩护标准进行修修补补。国会应该建立一个单向的费用转移机制,如果原告同意支付被告的发现费(如果他们的索赔被证明不成功),就允许原告获得上市前批准协议。收费转移是一种中间方法,既能更好地补偿原告,又不会过度震慑设备制造商。
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引用次数: 0
Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout". 从Scanadu的“Scout”中获得批准:众筹时代医疗器械监管的经验教训。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2015-01-01
Colleen Smith

Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.

互联网众筹是一种越来越受欢迎的新型融资方式,用于开发产品和企业。最近,它与美国食品和药物管理局(FDA)对医疗器械的监管发生了冲突。本文探讨了当公司在获得FDA批准之前通过众筹活动预售医疗设备时出现的问题。由于互联网众筹的使用只有几年的时间,学术上关于它的文章很少,特别是关于它与FDA法规的互动。人们对众筹的兴趣日益浓厚,再加上美国医疗器械行业投资的低迷,使得这一突出问题已经成熟,需要FDA进行审查。本文以医疗器械公司Scanadu在2013年开展的众筹活动为起点,为开发其家用诊断设备“Scout”筹集资金。由于开发一种设备并获得FDA批准的成本极高,医疗设备公司应该能够利用众筹来筹集必要的资金。然而,由于医疗设备可能带来的危险,FDA需要审查允许公司众筹医疗设备所带来的风险,并应发布指导意见,帮助公司遵守FDA的规定,同时仍允许他们利用众筹的好处。本指南应确保对消费者安全的持续承诺,这是FDA法规的核心。
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引用次数: 0
The Limits of FDA's Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing. 美国食品和药物管理局(FDA)监管涉及高通量 DNA 测序的临床研究的权力限度。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2015-01-01
Barbara J Evans

The United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation sequencing, to the agency's Part 812 investigational device exemption (IDE) regulation. Genome sequencing--for reasons explained in this article--blurs the line between categories of in vitro diagnostic (IVD) research that FDA traditionally has regulated and categories of research that FDA traditionally has not regulated. This blurring creates a risk that FDA may overstep its proper authority to regulate fundamental genomic and medical research. This article surveys the legal limits of FDA's authority'to subject genomic research to its IDE requirements. Section 1 explains that FDA has authority to regulate clinical investigations of devices, but is not authorized to regulate investigations that merely use devices to expand medical knowledge or to conduct fundamental research, unless special circumstances apply. Section 2 discusses the special circumstances that can expand or limit FDA's authority to regulate a specific clinical investigation, and Section 3 demonstrates these using an example. Section 4 explores concerns that arose in recent years about risks to human subjects in a certain type of investigation known as sponsor-investigator studies. In response to these concerns, FDA has suggested that it can regulate such studies in ways that threaten to expand FDA's regulation of research at academic medical centers beyond its proper scope. These concerns, while valid in some academic research contexts, seem inapposite in the setting of genomic research programs funded by responsible.entities such as the National Institutes of Health (NIH). Moreover, FDA's regulations do not. appear to support the proposition that FDA can regulate sponsor-investigator studies more expansively than it regulates other studies. Section 5 explores specific ways that NIH, clinical investigators, and FDA might work together to rationalize FDA's regulation of NIH-funded-genomic research.

美国食品和药物管理局(FDA)最近表示,有意将采用高通量基因测序(也称新一代测序)的临床研究纳入该局的第 812 部分研究设备豁免 (IDE) 法规。基因组测序--出于本文解释的原因--模糊了 FDA 传统上监管的体外诊断 (IVD) 研究类别与 FDA 传统上不监管的研究类别之间的界限。这种模糊造成了一种风险,即 FDA 可能会越权监管基础基因组和医学研究。本文探讨了 FDA 将基因组研究置于其 IDE 要求之下的权力的法律限制。第 1 节解释了 FDA 有权监管器械的临床研究,但无权监管仅使用器械扩展医学知识或进行基础研究的研究,特殊情况除外。第 2 节讨论了可扩大或限制食品及药物管理局监管特定临床研究的权力的特殊情况,第 3 节用一个例子说明了这些情况。第 4 节探讨了近年来出现的对某类调查中人类受试者所面临风险的关注,这 类调查被称为 "赞助者-调查者研究"。针对这些担忧,食品及药物管理局提出,它可以对这类研究进行监管,从而有可能将食品及药物管理局对学术医学中心研究的监管扩大到适当范围之外。这些担忧虽然在某些学术研究中是有道理的,但在由负责任的实体如美国国立卫生研究院(NIH)资助的基因组研究项目中似乎并不适用。此外,FDA 的法规似乎并不支持 FDA 可以比监管其他研究更广泛地监管赞助者-研究者研究的主张。第 5 节探讨了 NIH、临床研究者和 FDA 共同合作的具体方式,使 FDA 对 NIH 资助的基因组研究的监管合理化。
{"title":"The Limits of FDA's Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing.","authors":"Barbara J Evans","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The United States Food and Drug Administration (FDA) recently signaled its interest in subjecting clinical investigations that employ high-throughput gene sequencing, also called next-generation sequencing, to the agency's Part 812 investigational device exemption (IDE) regulation. Genome sequencing--for reasons explained in this article--blurs the line between categories of in vitro diagnostic (IVD) research that FDA traditionally has regulated and categories of research that FDA traditionally has not regulated. This blurring creates a risk that FDA may overstep its proper authority to regulate fundamental genomic and medical research. This article surveys the legal limits of FDA's authority'to subject genomic research to its IDE requirements. Section 1 explains that FDA has authority to regulate clinical investigations of devices, but is not authorized to regulate investigations that merely use devices to expand medical knowledge or to conduct fundamental research, unless special circumstances apply. Section 2 discusses the special circumstances that can expand or limit FDA's authority to regulate a specific clinical investigation, and Section 3 demonstrates these using an example. Section 4 explores concerns that arose in recent years about risks to human subjects in a certain type of investigation known as sponsor-investigator studies. In response to these concerns, FDA has suggested that it can regulate such studies in ways that threaten to expand FDA's regulation of research at academic medical centers beyond its proper scope. These concerns, while valid in some academic research contexts, seem inapposite in the setting of genomic research programs funded by responsible.entities such as the National Institutes of Health (NIH). Moreover, FDA's regulations do not. appear to support the proposition that FDA can regulate sponsor-investigator studies more expansively than it regulates other studies. Section 5 explores specific ways that NIH, clinical investigators, and FDA might work together to rationalize FDA's regulation of NIH-funded-genomic research.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":null,"pages":null},"PeriodicalIF":0.2,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4576719/pdf/nihms-708248.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33947020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges? 非传染性疾病疫苗的新浪潮:监管挑战是什么?
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2015-01-01
Jonathan J Darrow, Aaron S Kesselheim

Vaccines represent one of the greatest achievements of medicine, dramatically reducing the incidence of serious or life-threatening infectious diseases and allowing people to live longer, healthier lives. As life expectancy has increased, however, the burden of non-communicable diseases (NCDs) such as cancer, hypertension, atherosclerosis, and diabetes has increased. This shifting burden of disease has heightened the already urgent need for therapies that treat or prevent NCDs, a need that is now being met with increased efforts to develop NCD vaccines. Like traditional vaccines, NCD vaccines work by modulating the human immune system, but target cells, proteins or other molecules that are associated with the NCD in question rather than pathogens or pathogen-infected cells. Efforts are underway to develop NCD vaccines to address not only cancer and hypertension, but also addiction, obesity, asthma, arthritis, psoriasis, multiple sclerosis, and Crohn's disease, among others. NCD vaccines present an interesting challenge for the U.S. Food and Drug Administration (FDA), which is tasked with approving new treatments on the basis of efficacy and safety. Should NCD vaccines be evaluated under the same analytic frame as traditional vaccines, or that of biologic drugs? Despite the borrowed nomenclature, NCD vaccines differ in important ways from infectious disease vaccines. Because infectious disease vaccines are generally administered to healthy individuals, often children, tolerance for adverse events is low and willingness to pay is limited. It is important to have infectious disease vaccines even for rare or eradicated disease (e.g., smallpox), in the event of an outbreak. The efficacy of infectious disease vaccines is generally high, and the vaccines convey population level benefits associated with herd immunity and potential eradication. The combination of substantial population-level benefits, low willingness to pay, and low tolerance for adverse events explains the need for the federal National Childhood Vaccine Injury Compensation Act, which encourages production and uptake by providing immunity from liability to industry and compensation to injured patients. These characteristics and considerations contrast sharply with those of NCD vaccines, raising the question of whether the term "vaccine" is appropriate for this new category of drugs. The article explores the emerging class of NCD vaccines, explains how they differ from traditional vaccines, and describes some regulatory implications of this innovative type of therapeutic.

疫苗是医学最伟大的成就之一,它大大减少了严重或危及生命的传染病的发病率,使人们能够活得更长、更健康。然而,随着预期寿命的延长,癌症、高血压、动脉粥样硬化和糖尿病等非传染性疾病的负担有所增加。这种疾病负担的转移加剧了对治疗或预防非传染性疾病疗法的迫切需求,目前正在加大努力开发非传染性疾病疫苗来满足这一需求。与传统疫苗一样,非传染性疾病疫苗通过调节人体免疫系统起作用,但针对的是与非传染性疾病相关的细胞、蛋白质或其他分子,而不是病原体或被病原体感染的细胞。目前正在努力开发非传染性疾病疫苗,不仅用于治疗癌症和高血压,还用于治疗成瘾、肥胖、哮喘、关节炎、牛皮癣、多发性硬化症和克罗恩病等。非传染性疾病疫苗给美国食品和药物管理局(FDA)提出了一个有趣的挑战,FDA的任务是根据有效性和安全性批准新的治疗方法。非传染性疾病疫苗是否应在与传统疫苗或生物药物相同的分析框架下进行评估?尽管借用了术语,但非传染性疾病疫苗在许多重要方面与传染病疫苗不同。由于传染病疫苗一般是给健康人接种的,通常是儿童,因此对不良事件的耐受性较低,支付意愿有限。即使是针对罕见或已被根除的疾病(如天花),在疫情爆发时,拥有传染病疫苗也很重要。传染病疫苗的效力通常很高,并且疫苗具有群体免疫和潜在根除的人群水平的益处。大量的人口福利、低支付意愿和对不良事件的低容忍度的结合解释了联邦《全国儿童疫苗伤害赔偿法》的必要性,该法案通过免除工业责任和对受伤患者的赔偿来鼓励生产和使用。这些特点和考虑因素与非传染性疾病疫苗的特点和考虑因素形成鲜明对比,提出了“疫苗”一词是否适合用于这类新药物的问题。本文探讨了新兴的一类非传染性疾病疫苗,解释了它们与传统疫苗的不同之处,并描述了这种创新型治疗方法的一些监管意义。
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引用次数: 0
Probiotics: achieving a better regulatory fit. 益生菌:实现更好的调节契合。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Diane E Hoffmann, Claire M Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

The development and marketing of new probiotic products, substances containing live microorganisms that have a beneficial effect on the human body, have dramatically increased over the last few years. This article examines how the Food and Drug Administration and Federal Trade Commission currently regulate probiotics and makes recommendations as to changes that might be made to ensure that probiotic products are made available to the general public in a way that is both safe and effective.

新的益生菌产品,即含有对人体有益的活微生物的物质,其开发和销售在过去几年中急剧增加。本文研究了食品和药物管理局和联邦贸易委员会目前如何监管益生菌,并就可能做出的改变提出建议,以确保益生菌产品以安全有效的方式提供给公众。
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引用次数: 0
Challenging an immediate suspension of a DEA registration: is it time for a new tact? 挑战立即暂停DEA注册:是时候采取新策略了吗?
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Douglas J Behr

A Drug Enforcement Administration ("DEA") registration is not only a necessity, but also an invaluable commodity for doctors, pharmacists, hospitals and drug wholesalers who prescribe, stock, and distribute controlled substances. While the DEA may only suspend a registration by issuing an immediate suspension order ("ISO) after an ex parte finding of "imminent danger to the public health or safety," the law fails to explicitly protect the registrant by way of a post-suspension hearing on the ISO, despite the registrant's constitutionally protected property interest in the registration. A registrant has only two procedural options--which are often unsuccessful--to challenge the ISO: endure a long and arduous administrative review proceeding or petition the court for a "not-so-easily proven" injunction, all the while the suspension remains in effect and the controlled substance business operations cease. Accordingly, a suspension of the registration may be certain death to doctors and pharmacists without the financial means to operate the business in the absence of the registration. Because the DEA registration is a constitutionally-protected interest, there is a better way to challenge the suspension. The Supreme Court has held that once a license is issued, the continued possession of it is essential to the registrant's livelihood. Therefore suspension or revocation of such a protected interest requires due process. Due-process hearings, while varied, will provide the necessary avenues of review to provide a fair review of the justification of the suspension and its continuance, i.e., whether there truly is imminent danger to public health or safety and whether the suspension is overbroad and should be limited. To date, this thesis remains to be tested and awaits a petitioner with a justiciable claim and the financial resources to challenge the DEA in court. But in the field of DEA ISO challenges, it is time for a new tact!

对于开处方、储存和分发管制药物的医生、药剂师、医院和药品批发商来说,美国禁毒署(DEA)的注册不仅是必需品,而且是无价的商品。虽然DEA只能在单方面发现“对公众健康或安全的迫在眉睫的危险”后通过发布立即暂停令(“ISO”)暂停注册,但法律未能通过ISO暂停后听证会的方式明确保护注册人,尽管注册人在注册中的财产利益受到宪法保护。注册人只有两种程序选择——通常是不成功的——挑战ISO:忍受漫长而艰巨的行政审查程序,或向法院申请“不太容易证明”的禁令,在此期间暂停仍然有效,受控物质业务停止运营。因此,暂停注册可能会导致医生和药剂师在没有注册的情况下没有经营业务的财政手段而死亡。因为DEA注册是受宪法保护的利益,所以有更好的方式来挑战暂停。最高法院认为,一旦颁发许可证,继续持有许可证对注册人的生计至关重要。因此,暂停或撤销这种受保护的利益需要正当程序。正当程序听证会虽然各不相同,但将提供必要的审查途径,以公平审查暂停和继续暂停的理由,即是否真的对公共健康或安全构成迫在眉睫的危险,以及暂停是否过于广泛,应加以限制。到目前为止,这一论点仍有待检验,并等待请愿人提出可诉性索赔和财政资源,在法庭上挑战DEA。但是在DEA领域的ISO挑战中,是时候采取新的策略了!
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引用次数: 0
The grays of medical device color additives. 医疗器械颜色添加剂的灰色。
IF 0.2 4区 医学 Q4 Social Sciences Pub Date : 2014-01-01
Brenda Seidman

The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. Part 820, for material and vendor qualification and validation in general; approach Congress for needed statutory changes; or make administrative changes. In order for any approach to be successful, whether it is a new twist on past practices, or an entirely new path forward, the FDA must, to the best of its ability, better understand its past medical device color additive practices (as well as the variations that have developed within the last twenty or so years), and engage in a dialogue with stakeholders on how it and the medical device industry should consider unlisted color additives currently used in marketed devices in the United States.

美国的医疗器械颜色添加剂法规对一些人来说是未知的,对许多人来说是困惑的。本文回顾了经修订的《联邦食品、药品和化妆品法》(FFDCA)中关于颜色添加剂的法定语言,包括关于致癌性的德莱尼条款;联邦法规第21篇(cfr)第70-82部分中与医疗器械相关的颜色添加剂监管语言;关于美国食品和药物管理局(FDA)在处理医疗器械中颜色添加剂方面可能的当前和历史做法的报告;并推测可能是什么导致了几十年来看似特别的颜色添加剂的做法,现在可能很难重建和令人满意的修改。还讨论了设备和放射健康中心(CDRH)最近在其2013年4月指南草案第7节中对颜色添加剂的公开审查方法,使用国际标准ISO-10993,“医疗器械的生物评价第1部分:评估和测试”,作者认为这是朝着正确方向的改变,但是,至少在其目前的草案形式中,这并不能解决CDRH的颜色添加剂困境。最后,文章提出了CDRH在进一步开发颜色添加剂的新方法时可能考虑的问题。这种方法将把颜色添加剂视为任何其他潜在有毒的化学物质,并且可以以这样一种方式形成,即CDRH仍然可以满足国会颜色添加剂授权的广泛方面,并且。但与ISO 10993一致。在此过程中,CDRH需要建议更直接地使用其质量体系法规,21 cfr Part 820,用于材料和供应商的资格和验证;向国会提出必要的法律变更;或者进行管理上的改变。为了任何方法获得成功,是否一个新的转折在过去的做法,或一个全新的路径前进,FDA必须尽其能力,更好地了解它的过去医疗设备颜色添加剂实践(以及发达的变化在过去的二十年左右),并参与对它如何与利益相关者对话和医疗设备行业应该考虑未上市的颜色添加剂目前在销售设备在美国使用。
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