Physician Burnout: The Next Pandemic?
Second-Wave Contingency Planning and Risk Mitigation Strategies - Diagnosing Health Care Podcast
Long-Term Care Investigations: Critical Steps To Mitigate Risk and Protect Your Residents, Staff and Reputation
Compliance Perspectives: Health Care Compliance and the COVID-19 Virus
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
Defective medical devices present serious risks for patients. Just how big—and how severe—is the problem? Consider this from the U.S. Food and Drug Administration (FDA): “Each year, the FDA receives over two million medical...more
A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more
Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...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 In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell...more
The U.S. Food and Drug Administration (FDA) announced a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited – may introduce risks for certain Bluetooth enabled medical devices. ...more
The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more
On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02, approving an arrangement under which a pharmaceutical manufacturer provides...more
For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more
On the heels of an FDA committee report concerning cybersecurity issues with medical devices, the U.S. Food and Drug Administration (FDA) issued an alert regarding cybersecurity vulnerabilities, referred to as “URGENT/11,”...more
The blame and shame for the opioid-drug overdose crisis that kills tens of thousands Americans annually has moved to yet another set of individuals and institutions now — judges and courts that handled Big Pharma lawsuits and...more
Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the...more
The Food and Drug Administration (FDA) has issued a safety warning regarding the use of robotically assisted surgical devices for mastectomies and other cancer surgeries, asserting that "the safety and effectiveness of...more
Last week, the FDA issued a warning against the use of robotic surgery for mastectomy and other cancer-related procedures. ...more
On Jan. 15, 2019, Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a statement proposing policies to support cell and gene...more
Was Uloric Approval the Safe Decision? Attempts in 2005 and 2006 to obtain government-approval to sell Uloric were denied by the FDA due to concerns about research data that showed a slight elevation in the risks of death...more
• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more
The U.S. Food and Drug Administration (FDA) issued a statement on Dec. 20, 2018, once again putting stem cell companies on notice about its intention to crack down on the marketing of unapproved stem cell products, and...more
Welcome to the third issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues. For this edition, we are reporting on several important and timely legal issues. As you...more
On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
Opioid Education - The U.S. Food and Drug Administration (FDA) crept cautiously closer to curbing the opioid crisis by approving sweeping changes as to how the prescription drugs are labeled. Going forward, such...more
The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more