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Arnall Golden Gregory LLP

What’s New Pussycat? FDA Assists Drug Sponsors Requesting New Clinical Investigation Exclusivity

Key Takeaways - FDA explains what must be “new” to qualify for three years of non-patent market exclusivity. In a new draft Q&A guidance, FDA walks sponsors through what makes a clinical investigation “new,” how to support...more

Arnall Golden Gregory LLP

New Frontier: FDA Announces Draft Plausible Mechanism Framework for Individualized Ultra-Rare Disease Therapies

Key Takeaways - FDA has proposed a Plausible Mechanism Framework for ultra-rare disease therapies. The February 2026 draft guidance explains how sponsors may demonstrate safety and effectiveness when traditional randomized...more

Wiley Rein LLP

[Podcast] Poisoned Trust: The Farid Fata Scandal

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In this episode of Wicked Coin, Diana Shaw and Tatiana Sainati explore one of the most disturbing healthcare fraud schemes in U.S. history: a trusted oncologist who exploited patients’ deepest fears, administering often...more

McDonnell Boehnen Hulbert & Berghoff LLP

Quo Vadis mRNA Vaccine Technology? The State of the IP Lawsuits

One of the beneficial characteristics of the response to the COVID -19 pandemic were pledges from companies involved in developing vaccines (such as Moderna, Pfizer, BioNTech, and others) not to enforce patents on relevant...more

Seyfarth Shaw LLP

The Week in Weed: March 2026 #2

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Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, Oklahoma’s governor spoke out in favor of a medical marijuana ballot initiative. Florida will not see...more

Vorys, Sater, Seymour and Pease LLP

Pennsylvania Releases New Rates for Service Coordinators: Appeals Deadline April 7, 2026

On Friday, March 7, 2026, Pennsylvania’s Office of Development Programs (ODP) published final fee schedule rates for supports coordination (SC) and targeted supports management (TSM) services provided under Pennsylvania’s...more

McCarter & English, LLP

2025 NJ Statutory Updates: Part 1

2025 was another busy year for the New Jersey legislature in proposing and finalizing bills impacting health care. In this multipart update, we discuss the new bills and their impact on the healthcare industry in New Jersey....more

Association of Certified E-Discovery...

Breaking the Silence: How Two Legal Professionals Are Rewriting the Conversation on Mental Health

In an industry built on precision, pressure, and perfectionism, conversations about mental health often feel like forbidden territory. Yet on a recent episode of Mind Matters, Breaking the Silence in Legal Spaces, hosts Mike...more

Ropes & Gray LLP

Rare Disease in Focus at FDA: New Draft Guidance on Plausible Mechanism Framework for Individualized Therapies

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On February 23, 2026, FDA issued a highly anticipated draft guidance entitled “Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with...more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: Serent Invests in Saisystems

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Serent Capital has announced an investment in Saisystems Health. Saisystems, founded in 1987 and based in Shelton, Connecticut, is a provider of revenue cycle management and electronic health record solutions for physicians...more

A&O Shearman

Getting Ready For The EU Pharma Package: Key Changes To Regulatory Exclusivities, Orphan Medicinal Products And The “Bolar”...

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After the Council and the European Parliament have reached an agreement in the trilogue negotiations on the so-called Pharma Package in December 2025, the texts of the provisional agreement (comprising a new regulation and a...more

Benesch

Heightened Scrutiny Of Medicaid‑Funded ABA Services - Key Takeaways For Providers

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A recent investigative reporting by The Wall Street Journal highlights significant concerns within the Medicaid-funded autism therapy sector, particularly Applied Behavior Analysis (ABA). The article details how rapid...more

Lathrop GPM

[Webinar] Trump 2.0: One Year In – A Business Critical Look at Executive Orders and Actions - March 26th, 12:00 pm - 1:00 pm CT

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President Trump’s second term has produced a wave of administrative actions—more than 250 Executive Orders alone have been issued since January 20, 2025. These directives cover a wide range of business critical issues,...more

Shumaker, Loop & Kendrick, LLP

Client Alert: What Do Your Third-Party Payor Agreements Actually Require?

How in-depth has your entity reviewed its third-party payor agreements? Have your billing team, Compliance Officer, Privacy Officer, and Legal team all been made aware of requirements or, better yet, were they involved in the...more

ArentFox Schiff

Navigating the 2026 Life Sciences Legal Landscape

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As we continue to move through 2026, the life sciences landscape is shaped by a convergence of regulatory, enforcement, and market access developments that demand heightened attention from industry stakeholders....more

Foley & Lardner LLP

GLP‑1 Compliance: FDA Targets Telehealth Marketing in 30 New Warning Letters

Foley & Lardner LLP on

On March 3, 2026, U.S. Food & Drug Administration (FDA) sent 30 warning letters to telehealth companies that market compounded GLP‑1 products. These letters highlight FDA’s current enforcement priorities in the compounded...more

King & Spalding

Court Finds States Waived Sovereign Immunity by Filing in Federal Court in FCA Case

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On March 2, 2026, Judge Patti B. Saris of the District Court for the District of Massachusetts partially ruled in favor of Regeneron Pharmaceuticals on its motion to amend its answer in a qui tam case to assert contingent...more

Bergeson & Campbell, P.C.

ATSDR Updates Chemical Mixtures Interaction Profiles: Why They Matter for Risk Assessment and Regulation

The U.S. Agency for Toxic Substances and Disease Registry (ATSDR) recently released two new Interaction Profiles for Toxic Chemical Mixtures, continuing a long-running federal effort to better understand the health effects of...more

Cozen O'Connor

No Ifs, Ands, or Butts: Alaska Cracks Down on Illegal Tobacco

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Alaska AG Stephen Cox issued enforcement warning letters to more than 1,500 tobacco retailers and distributors for allegedly selling unauthorized electronic smoking devices and nicotine pouches in violation of federal and...more

Littler

New York Department of Health Issues Updated Guidance on Wage Parity Compliance Forms and Certification Submission Dates

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On March 9, 2026, the New York Department of Health (DOH) issued updated guidance for Licensed Home Care Services Agencies (LHCSAs), Medicaid Managed Care Organizations (MMCOs), Certified Home Health Agencies (CHHAs), former...more

Hinshaw & Culbertson - Privacy, Cyber & AI...

Compliance Considerations for GDPR Consent in Biotech Clinical Research - How One EU Framework Can Lead to Divergent Data...

Biotech and digital health teams working in Europe sometimes find that the hardest General Data Protection Regulation (GDPR) question in clinical research is not whether the law applies (it does), but how the different views...more

Herbert Smith Freehills Kramer

Pharma: Key UK legal developments from 2025

In this briefing, experts from multiple practice areas provide an overview of some of the key UK legal developments from 2025 which companies in the pharmaceutical sector should be aware....more

Haynes Boone

USPS Postmarking Changes Impact Benefit Plan Notices and Filings

Haynes Boone on

The United States Postal Service (“USPS”) recently issued a final rule that became effective December 24, 2025 to clarify the definition and application of postmarks. The rule provides that a postmark applied at a USPS...more

Ice Miller

The BIOSECURE Act in 2026: Rethinking Exposure in the Life Sciences Industry

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Over the past year, the BIOSECURE Act has transitioned from legislative debate to enacted federal law. The significance of this development lies not merely in the fact of enactment, but in the shift it represents: companies...more

Sheppard

DOJ’s FCA Head Shares Enforcement Insights

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Attendees of the Federal Bar Association’s annual Qui Tam Conference gained valuable insights from one of DOJ’s top False Claims Act enforcers last month. Commercial Litigation Branch Deputy Assistant Attorney General Brenna...more

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