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
Life Sciences Perspectives
Life Sciences Perspectives, published by Goodwin Procter, focuses on legal and regulatory developments affecting the life sciences sector. The blog covers topics such as pharmaceutical and biotechnology transactions, regulatory compliance for drugs, biologics, medical devices, diagnostics, and laboratory testing. It also addresses antitrust issues, healthcare fraud enforcement, data privacy regulations like the EU Data Act, and FDA programs impacting drug development and approval. The blog provides updates on policy changes, enforcement trends, and strategic considerations for companies and investors operating in the life sciences and medtech industries.
Latest from Life Sciences Perspectives - Page 18
Pharmaceutical Manufacturers Beware: New State Drug Transparency Laws and Enforcement Mechanisms Are Coming In 2022
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…
Don’t Forget about the States! Understanding the Maze of State Billing Laws for Physicians and Laboratories Providing Anatomic Pathology Services
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…
The Office of the National Coordinator for Health Information Technology Interoperability and Information Blocking Final Regulation: Key Concerns for Health Information Technology Companies and Developers
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…
List of Artificial Intelligence and Machine Learning (AI/ML)-enabled Devices Available on FDA’s Website
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…
Judge Dismisses Pfizer’s Lawsuit Over HHS Limits on Drug Copay Assistance
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…
Survival Guide to Structuring Life Sciences Partnering and M+A Agreements
By Publisher
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…
Federal Audits and Enforcement Actions of Telehealth Providers: Future Trends and Mitigating Risk
By Andrew Hess
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…
Goodwin Virtual Series: Foundations in Healthcare Compliance for Life Sciences Companies
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…
Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech
In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough Devices Program.” CMS’s proposal – the Medicare Coverage…