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(Podcast) The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
Hot Topics in International Trade A Year in Review (Quickly)
The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more
Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
Ozempic and other diabetes-weight loss drugs have been linked to at least 162 deaths and 10,000 cases involving “serious” injuries since 2018, according to data from the U.S. Food and Drug Administration (FDA)....more
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more
Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
In the hyper-connected era of smart manufacturing, accelerated by “Industry 4.0,” the manufacturing sector is undergoing a digital revolution. By leveraging technologies such as advanced automation, artificial intelligence,...more
The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled medical devices are playing a larger role in patient care. Such devices may use machine learning algorithms to...more
In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
Six months into the 117th Congress, the U.S. Senate has recently increased its oversight activities following a slow start. Since April, newly empowered Democratic Members have launched or requested more than 20 inquiries...more
On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more
Earlier this month, the California Insurance Commissioner announced that AbbVie had entered into a settlement agreement with the California Department of Insurance (CDOI) to resolve allegations that the pharmaceutical...more
On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical...more
On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and Emergency Preparedness Act (“PREP Act”) Declaration...more
Earlier this week, we discussed current trends and future implications of COVID-19 on businesses operating in the products arena, noting the most direct impact so far on the pharmaceutical and medical device spaces....more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences...more
Dean Foods, the largest milk company in the U.S., has filed for bankruptcy protection, a “fresh setback to a U.S. dairy industry struggling against declining U.S. milk consumption and rising competition.” Industry experts...more
On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more
Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots of...more
It’s that time of year again—the end of one and beginning of another—when we pause, reflect and look forward to the year ahead. In this retrospective, we consider the past year’s legal developments in the drug and medical...more