Goodwin is pleased to invite you to our Life Sciences Disputes webinar series, which will highlight current topics across our Securities Litigation and Antitrust practice areas that affect life sciences companies. Trends and Hot Topics in Securities Litigation and SEC Enforcement for the Life Sciences Industry November 9, 2021…
For emerging companies establishing their first supply chains, ensuring notification requirements in supply agreements for when commercial-stage manufacturing issues arise may not be top of mind. However, it is important for drug developers whose contracts enable continuation of a supply arrangement into the commercial-stage to be familiar with the U.S….
In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and other information related to the cost, development, and sale of drugs. By October 2021, approximately twenty states have passed…
Laboratory tests play a critical part of the healthcare system. Ordering and billing for these tests, however, is not always cut-and-dry. Compliance with federal laws and rules (like the Clinical Laboratory Improvement Amendments (CLIA), the Anti-Kickback Statute (AKS), and the Eliminating Kickbacks in Recovery Act (EKRA) – not to mention…
As of April 5, 2021, health information technology companies and developers are required to comply with the information blocking provisions of the Centers for Medicare and Medicaid Services’ (CMS) and the Office of the National Coordinator for Health Information Technology’s (ONC) Information Blocking Final Regulation (“Final Rule”), implementing specific provisions…
The U.S. Food and Drug Administration (FDA) now provides a list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices that are legally marketed in the United States. These include devices (1) cleared via 510(k) premarket notifications, (2) authorized pursuant to De Novo requests, and (3) approved via premarket approval applications, or…
In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer against the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General’s (“OIG”) over Pfizer’s drug…
The life sciences space is ever-growing and dynamic as the industry witnesses more companies and, therefore, more collaboration, licensing and M&A agreements, come into the spotlight. While these deals are exciting opportunities for life sciences companies at all stages, they can also be daunting when it comes to their legal…
As the COVID-19 pandemic progresses and the expanded use of telehealth has appeared to stabilize over the past year according to a July report from McKinsey & Company, Federal agencies have continued the recent trend of enforcement actions and audits of telehealth providers. On September 17, 2021, the U.S. Department…
In the ever-evolving life sciences industry, compliance is top-of-mind for investors, business leaders, the public and the government. Life sciences companies are subject to increased enforcement efforts and greater public scrutiny, and boards, investors, and other key stakeholders call for more and better compliance controls. As a result, there are…