Krista Carver

Krista Carver

Krista Hessler Carver advises medical device,生物技术,pharmaceutical and cosmetic manufacturers and trade associations on a wide range of FDA regulatory,顺从,transactional,and legislative matters.Ms.Carver has particular experience with legal and regulatory issues related to biosimilars,medical devices,combination products,以及个性化的药物。

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即将举行的网络研讨会:eHealth产品和移动应用程序监管(2月25日,2015)

作为科文顿正在进行的生vwin真人视讯命科学要领网络研讨会系列的一部分,我们将于2月25日推出一个关于电子健康产品和移动应用程序监管的计划。2015年(下午12:30-2:00EST).我们的小组成员,including two alumni of the FDA Office of Chief Counsel,will address: What factors determine whether an eHealth product is considered a medical device … 继续阅读

Upcoming Webinar: Trends in Pharmaceutical and Medical Device Patent Litigation (February 11,2015)

作为Covingtonvwin真人视讯正在进行的生命科学基础网络研讨会系列的一部分,我们将于2月11日推出一个关于制药和医疗器械专利诉讼趋势的项目,2015年(下午12:30-2:00EST).小组成员和主题包括:莎拉阿诺夫——ITC第337节专利诉讼的当前趋势,包括不断发展的国内产业需求和… 继续阅读

国家食品药品监督管理总局提出新的医疗器械试验场所认定规定。

On December 15,2014,the China Food and Drug Administration released proposed Measures for the Accreditation of Medical Device Clinical Trial Institutions (Measures) for public comment.这些评论将于2月28日发表。2015。这些措施清楚地说明了中国医疗机构向政府申请成为合格医疗机构的过程。 继续阅读

FDA发布510(k)德赢真人视讯次转移的指导草案

In late December 2014,FDA发布了一份指南草案,标题为德赢真人视讯:“上市前通知(510(k))放行的转让——问题和答案”,它向行业提供了有关如何将510(k)放行从一个人转移到另一个人的信息。指南草案还概述了食品和药物管理局工作人员和行业应……德赢真人视讯 继续阅读

China Issues Multiple Final Rules and Proposals to Implement Recent Revisions to its Core Medical Device Regulation

Throughout August 2014,the China Food and Drug Administration (CFDA or the Agency) made significant process in issuing finalized rules and guidances to implement the revisions to its core medical device regulation,the Medical Device Supervision and Administration Regulation (MDR) (see our alert,here).  The State Council revised the MDR in March,它去了… 继续阅读

Supreme Court Seeks Solicitor General's Views on Cert Petition in Closely-Watched Preemption Case

一月,我们写了关于第九巡回法院在斯坦格尔诉案中有争议的裁决。Medtronic,holding that the plaintiff's product liability claims,其前提是美敦力声称未能向FDA报告关于其止痛药泵的批准后信息,没有先发制人。对于案件的详细讨论,please refer to our previous post.  … 继续阅读

Privacy Impact Assessments – Soon Compulsory for Companies in the Life Sciences Industry?

As discussed in our previous post on our sister blog Inside EU LifeSciences,隐私影响评估(PIA)或数据保护影响评估曾在特定技术或行业领域进行讨论(见for instance,the European Commission's recommendations in relation to applications supported by radio-frequency identification (RFID) and the development of smart grids).However,… 继续阅读

Senator Leahy is the Latest to Pressure NIH to Exercise Bayh-Dole March-In Rights

An issue device manufacturers may not always fully consider when developing products from government-funded research is the Bayh-Dole Act's authorization for a federal funding agency (for drugs and devices,often the National Institutes of Health) to "march-in" to the intellectual property rights of the inventor.  Although,to date,国家卫生研究院拒绝行使它的… 继续阅读

联盟试图推迟移动医疗应用程序的指导

This July will mark the two-year anniversary of FDA releasing its 德赢真人视讯draft guidance document,德赢真人视讯Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications.  Finalizing the guidance document is listed as an "A list" item on the Center for Devices and Radiological Health's proposed guidance development for Fiscal Year 2013,和… 继续阅读

FDA发布医疗器械网络德赢真人视讯安全指导文件草案

去年,美国食品和药物管理局一直在关注网络安全问题,due in part to a Government Accountability Office report issued last August that urged FDA to consider the risk of intentional threats to device information security.  Although the GAO report noted that FDA was not aware of any actual incident of device … 继续阅读

Lessons from FDA's First Public Mobile Medical Apps Enforcement Letter

As we discussed in a previous post,5月22日,美国食品药品监督管理局对一家移动应用程序开发商采取了首次公开宣布的执法行动。issuing an "It Has Come to Our Attention Letter" to India-based app developer,这封信得到了广泛的媒体报道,而mhealth部门立即充满了兴趣(和关注)。 继续阅读

可穿戴式传感器市场的增长将新的重点放在了难以解决的监管问题上。

本周数字医疗行业传出了一个大消息,when Jawbone announced that it would acquire BodyMedia,reportedly for more than $100 million.  Both companies market products in a rapidly growing sector of the digital health industry:  wearable sensors that track and analyze users' lifestyles.  Jawbone's UP can track sleep,运动,和饮食,… 继续阅读

FDA Tells Congress to Expect Final Guidance on Mobile Medical Apps This Year

正如我们之前报道的,移动医疗应用程序的监管仍然是国会关注的问题。the Republican-led House of Representatives Energy and Commerce Committee held three days of hearings addressing how FDA regulation and the medical device tax could affect innovation in mobile applications and devices,how technological advancements … 继续阅读

Device Companies May Seek an Increase in Federal Supply Schedule Contract Prices to Accommodate Device Tax

As we've previously described,Section 4191 of the Internal Revenue Code imposes a 2.3% excise tax on the sale of certain medical devices by the manufacturers/importers of the devices.2012年12月,美国国税局(IRS)发布了有关确定销售价格的最终条例和临时指导意见,以及与……有关的其他问题。 继续阅读

对FDA移动医疗应用规范的再思考

In the Winter/Spring edition of the SciTech Lawyer,published by the American Bar Association's Section of Science & Technology Law, Scott Danzis and Chris Pruitt argue that FDA should rethink its approach to regulating mobile medical apps,包括对指导文件草案进行重大修订,德赢真人视讯德赢真人视讯工业和食品药品管理局工作人员指南草案:移动… 继续阅读

Caronia最新消息:政府对第二巡回法庭的重大决定不提出上诉

The federal government will not appeal the decision of a Second Circuit panel in United States v.卡罗尼亚。政府没有在1月16日的最后期限前请求专家组或欧洲央行第二巡回法庭重新审理。此外,the Wall Street Journal and others are reporting that FDA officials have confirmed that the government … 继续阅读

FDA最近四封关于设备广告/促销活动的警告信摘要

In November,美国食品和药物管理局(FDA)设备和放射卫生中心(CDRH)的合规办公室(OC)在其网站上发布了四封与医疗设备广告和推广有关的警告信:给Quanta系统的警告信,S.p.A.re: Quanta Q-Plus (Q-Plus Series) and Light Series Laser models (October 18,2012) Warning letter to NeuroMed Devices,Inc.… 继续阅读

U.S.v.诉Caronia: Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion

On December 3,2012,the United States Court of Appeals for the Second Circuit issued a significant opinion in United States v.Caronia,concerning the application of the First Amendment to off-label promotion.The court held that "the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Federal Food,药物,和化妆品法案]为… 继续阅读

"TEST Act": Newly Enacted Law Grants CMS Discretion for Sanctioning Referral of Proficiency Tests

On Tuesday,President Obama signed into law the "Taking Essential Steps for Testing Act of 2012," H.R.6118,granting the Centers for Medicare and Medicaid Services (CMS) discretion to choose appropriate sanctions for clinical laboratories that are found to have intentionally referred proficiency test samples in violation of the Clinical Laboratory Improvement Amendments (CLIA).In … 继续阅读

ABA Section of Science & Technology Law Creates New Medical Devices Committee

The medical devices industry is a global industry at the forefront of medical technology and innovation.  And the ABA's Section of Science & Technology Law (SciTech) explores emerging issues at the intersection of law,科学,和技术。今年秋天,SciTech launched a new medical devices committee to advance public understanding and shape the development of law and … 继续阅读
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