Health Law Advisor

Today, on April 29, 2024, following more than a decade of discourse, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released its long-awaited “Medical Devices; Laboratory Developed Tests” Final Rule (the “Final Rule”) formalizing the Agency’s authority to regulate laboratory developed tests (“LDTs”) as medical devices.

Since FDA issued its Proposed Rule (the “Proposed Rule”) in the Fall of 2023, Epstein Becker Green (EBG) and other industry stakeholders have eagerly awaited FDA’s issuance of the Final Rule and have speculated as to the provisions the Agency would choose to finalize.

Now, with the wait finally over, EBG joins the rest of industry in our review of the Final Rule, and we will be preparing a more in-depth analysis of the Final Rule and its potential impact on laboratories and the nationwide healthcare system. For now, here are important preliminary takeaways from the Final Rule.

In this episode of the Diagnosing Health Care Podcast:  What has contributed to the biotechnology industry’s explosive growth over the last several years? In this episode, special guests Don and Lisa Drakeman, two former CEOs of biotech companies, reflect on what it takes to succeed, the regulatory challenges they have faced, and how current events are shaping the future of the industry.

In this episode of the Diagnosing Health Care Podcast:  This term, the Supreme Court of the United States is set to rule in a Medicare reimbursement case that has sparked a fresh look at the historical deference often granted to agencies and whether it should remain, be modified, or even be overruled.

Attorneys Stuart Gerson, Robert Wanerman, and Megan Robertson discuss why Chevron deference matters to health care industry stakeholders and what aspects of deference arguments should be in focus as these cases progress.

The Diagnosing Health Care podcast series examines the ...

On October 24, 2016 the Food and Drug Administration ("FDA") in conjunction with the Centers for Medicare & Medicaid Services ("CMS") announced their intention to extend the Parallel Review pilot program indefinitely. The Parallel Review process is intended to provide timely feedback on clinical data requirements from FDA and CMS, and minimize the time required for receiving Medicare coverage nationally.  Sounds good.  So, why have so few manufacturers taken advantage of the program to date?

Despite its admirable goals, the current Parallel Review Process is too limited in scope ...