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Insights on Life Sciences

384 total results. Page 1 of 16.

Events
Medicaid Drug Rebate Program (MDRP) Summit 2025 - Master Complex Regulatory Guidelines to Deliver Compliant Government Pricing and Reporting Programs
September 15, 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.

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.”

Investigations Blog
Co-Founder and Accountant of Leading Special Needs Trusts Charged in $100 Million Alleged Fraud Scheme
June 27, 2025
D. Jacques Smith, Nadia Patel, Hillary M. Stemple, Michelle J. Shapiro, James G. Pizzo, Heather M. Zimmer

Headlines that Matter for Companies and Executives in Regulated Industries

Press Release
ArentFox Schiff Welcomes Former FDA Regulator in Washington
June 25, 2025

ArentFox Schiff is pleased to announce that Abha Kundi has joined the firm as Counsel in the Food, Drug, Medical Device & Cosmetic practice in Washington, DC.

Customs & Import Compliance Blog
As the (Customs and Trade) World Turns: June 2025
June 16, 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, Terry M. Frederic, Andrew McArthur

Welcome to the June 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
DOJ Criminal Division Head Details White-Collar Enforcement Priorities and Related Policy Revisions
June 13, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, John M. Hindley, Pascal Naples

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
FCA Enforcement & Compliance Digest — Summer 2025 False Claims Act Newsletter
June 12, 2025
D. Jacques Smith, Nadia Patel, Hillary M. Stemple, Michelle J. Shapiro, Apeksha Vora, Rebekkah R.N. Stoeckler, Nardeen Billan

Welcome to the Summer 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance tips. 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.

Alerts
DTP: Legal Insights for Pharma Communications
June 6, 2025
Stephanie Trunk

Life Sciences Partner Stephanie Trunk and Life Sciences Regulatory and Compliance Attorney Darshan Kulkarni delve into the nuances of direct-to-patient (DTP) and direct-to-consumer (DTC) models in the pharmaceutical industry.

Investigations Blog
CEO of Health Care Software Company Convicted of $1 Billion in Medicare Fraud
June 6, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Roberto Martinez, John M. Hindley

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
Two Charged in Alleged $227 Million COVID-19 Test Kit Fraud
May 30, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Heather M. Zimmer, Roberto Martinez, Meghan F. Hart

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
DOJ Plans to Use the FCA to Attack DEI Initiatives
May 23, 2025
D. Jacques Smith, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Laura Zell, Michelle J. Shapiro, Meghan F. Hart, Rebekkah R.N. Stoeckler

Headlines that Matter for Companies and Executives in Regulated Industries

Events
Pricing & Contracting USA 2025
May 21, 2025
Stephanie Trunk

Health Care Partner Stephanie Trunk will participate in the External Counsel Fireside Chat at Informa Connect’s Pricing & Contracting USA 2025 conference in Philadelphia, Pennsylvania, on May 21.

Investigations Blog
DOJ Announces Updated White-Collar Enforcement Priorities and Revised Policies
May 16, 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

Customs Newsletter Featured Web Banner
Customs & Import Compliance Blog
As the (Customs and Trade) World Turns: May 2025
May 15, 2025
Angela M. Santos, Antonio J. Rivera, John Gurley, D. Reed Freeman Jr., Diana Dimitriuc Quaia, James Kim*, Lucas A. Rock, Mario A. Torrico, Maya S. Cohen, Tyler J. Kimberly, Andrew McArthur, Joy Marie Virga

Welcome to the May 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.

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