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Insights on Life Sciences

396 total results. Page 1 of 16.

Investigations Blog
$37 Million FCA Settlement: Semler Scientific and Bard Resolve Medicare False Claims Over FloChec/QuantaFlo
October 6, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Mattie Bowden, Rebekkah R.N. Stoeckler

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care Counsel Blog
FDA Launches National Sweep of Deceptive Drug Advertisements
September 30, 2025
Stephanie Trunk, Shoshana Golden, Emily Cowley Leongini

Earlier this month, the US Department of Health and Human Services (HHS) and US Food and Drug Administration (FDA) announced a nationwide crackdown on direct-to-consumer (DTC) drug advertisements.

Investigations Blog
Remarks by Acting Assistant Attorney General Matthew R. Galeotti Regarding White Collar Enforcement Priorities
September 29, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Apeksha Vora, Rebekkah R.N. Stoeckler

Headlines that Matter for Companies and Executives in Regulated Industries

Alerts
FDA Issues Guidance on Alternative Tools for Assessing Drug Manufacturing Facilities in Pending Applications
September 23, 2025
Abha Kundi*

On September 12, the US Food and Drug Administration (FDA) released guidance detailing its approach to using alternative tools, such as remote regulatory assessments (RRAs), information sharing with foreign regulators, and virtual inspections, to evaluate drug manufacturing facilities identified in pending marketing applications.

Investigations Blog
Ninth Circuit Restores FCA Case Against Biotronik
September 22, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Heather M. Zimmer, Rebekkah R.N. Stoeckler

Headlines that Matter for Companies and Executives in Regulated Industries

Events
Medicaid Drug Rebate Program (MDRP) Summit 2025 - Master Complex Regulatory Guidelines to Deliver Compliant Government Pricing and Reporting Programs
September 17, 2025
Stephanie Trunk

The Medicaid Drug Rebate Program (MDRP) Summit 2025 will be held in Chicago, IL, from September 15-17, 2025. This hybrid event is hosted by Informa Connect and will feature topics such as 340B, drug pricing policy, and the Inflation Reduction Act (IRA), designed to aid attendees in mastering complex regulatory guidelines.

Customs & Import Compliance Blog
As the (Customs and Trade) World Turns: September 2025
September 16, 2025
Angela M. Santos, Antonio J. Rivera, Megan Barnhill, Nadia Patel, Jackson David Toof, Christopher H. Skinner, Kay C. Georgi, James Kim*, Lucas A. Rock, Mario A. Torrico, Maya S. Cohen, Derek Ha, Natalie Tantisirirat

Welcome to the September 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

Investigations Blog
Omni Healthcare Ordered to Pay Attorney Fees for Vexatious FCA Litigation
September 15, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Roberto Martinez, Heather M. Zimmer

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
Seventh Circuit Affirms Dismissal of FCA Retaliation Suit Against AbbVie for Alleged Off-Label Promotion
September 8, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Pascal Naples, James G. Pizzo

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
DOJ Files Brief in Johnson & Johnson’s Appeal of $1.6 Billion FCA Verdict
September 2, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Roberto Martinez, Pascal Naples

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
Allied Stone Inc. and Its President Agree to Pay $12.4 Million to Settle FCA Claims Relating to Evaded Customs Duties
August 25, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, John M. Hindley, Roberto Martinez

Headlines that Matter for Companies and Executives in Regulated Industries

Customs & Import Compliance Blog
As the (Customs and Trade) World Turns: August 2025
August 18, 2025
Angela M. Santos, Megan Barnhill, Nadia Patel, Jackson David Toof, Christopher H. Skinner, Kay C. Georgi, Sylvia G. Costelloe, James Kim*, Mario A. Torrico, Maya S. Cohen, William G. Stroupe II, Terry M. Frederic, Derek Ha, Andrew McArthur, Yusra H. Siddique

Welcome to the August 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

Investigations Blog
Texas Alleges That Eli Lilly Patient Assistance Programs Violates AKS
August 15, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Shoshana Golden, John M. Hindley

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
Regeneron Court Permits Government to Pursue False Certification Theory
August 8, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Shoshana Golden

Headlines that Matter for Companies and Executives in Regulated Industries

Events
HDA 2025 Traceability Seminar
August 5, 2025
Abha Kundi*

Food, Drug, Medical Device & Cosmetic Counsel Abha Kundi will deliver the opening presentation of the Healthcare Distribution Alliance’s (HDA) 2025 Traceability Seminar on August 5, 2025.

Alerts
HHS Announces 340B Rebate Model Pilot Program
August 4, 2025
Stephanie Trunk, Shoshana Golden

On July 31, the US Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced the availability of a new pilot program altering how pharmaceutical manufacturers can honor the 340B price.

Investigations Blog
Patio Furniture Firm Pays Millions for Dodging Import Duties
August 1, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Elizabeth Satarov, Meghan F. Hart

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care Counsel Blog
Medicare 2026 Proposed Rules, Major Drug Pricing Updates, and What Stakeholders Need to Know
July 25, 2025
Stephanie Trunk

Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules that set Medicare reimbursement and shape the administration of the Medicare Part B program for the upcoming calendar year. These rules are the Physician Fee Schedule (PFS) proposed rule and the Hospital Outpatient Prospective Payment System (HOPPS) proposed rule.

Investigations Blog
Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict
July 25, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Pascal Naples, Elizabeth Satarov

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care Counsel Blog
AI Service Agreements in Health Care: Indemnification Clauses, Emerging Trends, and Future Risks
July 23, 2025
Douglas A. Grimm

As artificial intelligence (AI) becomes increasingly embedded in health care, from diagnostics and clinical decision support to administrative automation, health care providers are increasingly reliant on AI vendors to deliver accurate, safe, and compliant solutions, subject to applicable regulatory requirements and standards of care.

Investigations Blog
IT Company Resolves FCA Allegations for Nearly $15 Million
July 18, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Apeksha Vora, Nardeen Billan

Headlines that Matter for Companies and Executives in Regulated Industries

Customs & Import Compliance Blog
As the (Customs and Trade) World Turns: July 2025
July 14, 2025
Angela M. Santos, Antonio J. Rivera, Megan Barnhill, Nadia Patel, Jackson David Toof, Matthew Tuchband, James Kim*, Lucas A. Rock, Mario A. Torrico, Maya S. Cohen, Derek Ha, Denny Peixoto

Welcome to the July 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

Investigations Blog
Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS
July 11, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Apeksha Vora, Heather M. Zimmer, Rebekkah R.N. Stoeckler

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
DOJ and HHS Emphasize Continued, Robust, and Coordinated Health Care Enforcement With Revival of False Claims Act Working Group
July 8, 2025
D. Jacques Smith, Nadia Patel, Michelle J. Shapiro, Stephanie Trunk, Pascal Naples, Rebekkah R.N. Stoeckler

The government has announced a renewed and expanded focus on False Claims Act (FCA) enforcement, doubling down on traditional health care priorities like kickbacks and drug pricing while signaling increased scrutiny of Electronic Health Records (EHR) manipulation.

Alerts
FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight
July 1, 2025
Abha Kundi*

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”

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