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Akin Gump Strauss Hauer & Feld LLP

FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more

Bradley Arant Boult Cummings LLP

North Carolina Governor Forms a [High] Council on Cannabis

On June 4, North Carolina Gov. Josh Stein issued an executive order creating the North Carolina Advisory Council on Cannabis. Stein elaborated on this decision in a recent interview with WRAL News. The High Council (yes,...more

McDermott+

Healthcare Extenders Tracker (July 2025 Update)

McDermott+ on

Many healthcare programs are extended for specific time periods, as short as one or two years or as long as 10, and are usually attached to a larger piece of must-pass legislation. Additionally, while traditional...more

Sheppard Mullin Richter & Hampton LLP

Rhode Island Enacts Ban on Reporting Medical Debt to Credit Bureaus

On June 26, Rhode Island Governor Dan McKee signed companion bills S 0169 and S 0172 into law, twin measures that amend the state’s Deceptive Trade Practices Act and Interest and Usury statute to impose some of the nation’s...more

Sheppard Mullin Richter & Hampton LLP

Key Insights from Sheppard Mullin and Marsh McLennan’s Webinar on Navigating Healthcare Risks in a Rapidly Evolving AI Landscape

On June 10th, Sheppard Mullin partner Carolyn Metnick and associate Esperance Becton, in collaboration with Marsh McLennan, presented the CLE webinar, “Navigating Healthcare Risks in a Rapidly Evolving Patient and Provider...more

Perkins Coie

FDA Human Foods Program Details 2025 Guidance Agenda: Key Topics and Priorities

Perkins Coie on

Key Takeaways: - The FDA Human Foods Program (HFP) released its agenda for releasing draft guidance for the remainder of 2025. - The agenda includes new guidance on topics such as new dietary ingredient notifications, food...more

McDermott Will & Emery

5 Questions with a Health Lawyer: Charles Buck

McDermott Will & Emery on

What is your favorite part of practicing healthcare law at McDermott? Healthcare is a complicated, heavily regulated industry. Government is also the primary payor in the industry. As a result, lawyers with deep knowledge...more

Goodwin

FDA’s Push for “Radical Transparency”: Key Takeaways from the Agency’s Publication of Complete Response Letters

Goodwin on

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced publication of over 200 complete response letters (CRLs) issued in response to applications submitted to FDA for approval of drugs or biologics between...more

Rivkin Radler LLP

DOJ and HHS Announce FCA Working Group

Rivkin Radler LLP on

On July 2, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced the formation of the DOJ-HHS False Claims Act Working Group to strengthen “their ongoing collaboration to advance...more

Cozen O'Connor

AGs Renew Call for FDA Guidance on Toxic Heavy Metals in Baby Food

Cozen O'Connor on

Arizona AG Kris Mayes and D.C. AG Brian Schwalb submitted a letter to the FDA in support of other state AG’s 2022 petition for reconsideration of a multistate petition seeking FDA actions on toxic heavy metals in food...more

Cozen O'Connor

Democratic AGs Sue HHS, DHS Over Alleged Health Data Sharing

Cozen O'Connor on

20 Democratic AGs sued HHS and DHS for allegedly sharing personal health data with ICE. The complaint alleges that the Centers for Medicare & Medicaid Services—a division of HHS—transferred millions of individuals’ Medicaid...more

McGuireWoods LLP

OIG Approves Multi-MSO Telehealth Arrangement That Meets AKS Safe Harbor

McGuireWoods LLP on

On June 6, 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion concerning a proposed telehealth staffing and services arrangement involving a management...more

Hogan Lovells

What’s next for UK HFSS regulation?

Hogan Lovells on

First introduced in 2007 and ramping up in the last few years, several restrictions have been put in place in the UK to limit the promotion and advertising of food and drink products that are high in fat, sugar or salt...more

Gould + Ratner LLP

10 Things a Real Estate Investor Should Know About the Big Beautiful Bill

Gould + Ratner LLP on

On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was passed into law and introduced many changes to the tax code and federal spending priorities. The OBBBA has wide-ranging implications for the real estate market. Here...more

Blake, Cassels & Graydon LLP

Ontario : Nouveau guide de gestion de la protection de la vie privée à l’intention des petits organismes de soins de santé

La Commissaire à l’information et à la protection de la vie privée de l’Ontario (la « CIPVP ») a publié un nouveau guide de gestion de la protection de la vie privée (le « Guide ») ayant pour but d’aider les petits organismes...more

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

Bergeson & Campbell, P.C.

OECD Publishes Case Study on 2D Titanium Carbide MXenes 

On June 30, 2025, the Organisation for Economic Co-operation and Development (OECD) published a report entitled 2D Titanium Carbide MXenes: Case Study Report on Advanced Materials. Within OECD’s Working Party on Manufactured...more

ArentFox Schiff

Potential Impacts of the ‘One Big Beautiful Bill’ on the District of Columbia

ArentFox Schiff on

The newly enacted “One Big Beautiful Bill,” formally known as the Legislation for Reconciliation and Policy Reforms 2025, contains a range of provisions that bear unique significance for the District of Columbia....more

King & Spalding

District Court Orders CVS Caremark to Pay U.S. Government $95 Million

King & Spalding on

On June 25, 2025, Chief Judge Mitchell S. Goldberg of the U.S. District Court for the Eastern District of Pennsylvania issued a ruling in the case of U.S. ex rel. Sarah Behnke v. CVS Caremark Corp. et al., ordering CVS...more

Foley & Lardner LLP

Key Texas Insurance Bills From the 89th Regular Legislative Session

Foley & Lardner LLP on

The topic of insurance often causes glazed eyes in some readers not immersed in the industry, but insurance was a hot topic coming into the 89th Regular Session of the Texas Legislature. Interest stemmed not only from ongoing...more

Mintz - Health Care Viewpoints

FDA in Flux — July 2025 Newsletter

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

Cozen O'Connor

Pennsylvania Perspective for Thursday, July 10, 2025

Cozen O'Connor on

Gov. Shapiro Warns About Medicaid Cuts, Rural Hospital Closures - During a press conference in York on Monday, Governor Josh Shapiro (D) sharply criticized Pennsylvania Republicans for supporting a federal reconciliation...more

Seyfarth Shaw LLP

From Telehealth to Trump Accounts: Breaking Down the One Big Beautiful Bill’s Impact on Employee Benefits

Seyfarth Shaw LLP on

On July 4, 2025, Donald Trump signed the One Big Beautiful Bill (OBBB) into law. Although most have focused on the sweeping tax reform included in the OBBB, a number of key employee benefits provisions are included in the...more

Bodman

DOJ Data Security Program – Another Privacy and Security Law that Impacts the Health Care Industry

Bodman on

The Department of Justice (“DOJ”) implemented the Data Security Program (“DSP”) intending to prevent access to Americans’ bulk sensitive personal data and government-related data by Countries of Concern. The DSP is aimed at...more

Epstein Becker & Green

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

Epstein Becker & Green on

On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....more

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