Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Medicaid Cuts: Potential Challenges and Legal Implications for Long-Term Care Facilities — Assisted Living and the Law Podcast
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Hospice Insights Podcast - One Size Doesn’t Fit All: Figuring Out What is Your Hospice+
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 220: Healthcare Regulation Under the Trump Administration with Bob Coble of Maynard Nexsen
Health Policy Update: Impact of the 2024 U.S. Elections – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 206: Supporting Patient Care with Darra Coleman of Prisma Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of Need with Rebecca Thornhill of Maynard Nexsen
A Fond Farewell: Musings on the End of the Medicare Advantage Hospice Carve-In Demonstration
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 178: Life Sciences Industry Impact with Bob Coughlin, JLL Director and Former MassBio CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 175: Healthcare Inequity with Kim Smith, Healthcare Advocate and Founder of Health Evolve Technologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 173: Improving rural health care with Dr. Kevin Bennett, the Director of the Research Center for Transforming Health and the
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
The No Surprises Act: A Cost Saving Opportunity for Employer Plan Sponsors
La reforma del sistema de salud
Counsel That Cares - Value-Based Care as a Long-Term Investment
Podcast: 2023 Health Policy Outlook - Diagnosing Health Care
Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more
Artificial Intelligence (AI) continues to revolutionize industries and is poised to bring transformative change in healthcare delivery, drug discovery, diagnostics, and data analysis and communication. This technology is...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
On June 10, 2025, FDA Commissioner Martin A. Makary and Chief Medical and Science Officer Vinay Prasad published an article in the Journal of the American Medical Association titled, “Priorities for a New FDA.”1 The article...more
On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more
Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more
Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more
In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...more
To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more
On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more
On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more
Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk drug lists, announcing the end of FDA’s 2017 interim policies. Under the new...more
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more
After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more
Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more
This week, FDA published a proposed rule that would amend its medical product "intended use" regulations, 21 CFR §§ 201.128 and 801.4 and replace the 2017 Final Rule about the same issue that never became effective....more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA...more