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Insights on Life Sciences

507 total results. Page 1 of 21.

Customs & Import Compliance Blog
As the (Customs and Trade) World Turns: October 2026
October 26, 2026
Angela M. Santos + 13

Welcome to the October 2026 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 Launches Fraud Whistleblower Incentive Program Offering Rewards for Tips Leading to Criminal Charges
October 26, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
DOJ Fraud Division Issues Directive Outlining a ‘Comprehensive Approach’ to Fraud Enforcement
October 19, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
Heal 360 Owner and Clinics Agree to Pay $20 Million to Resolve FCA Allegations Involving COVID-19 Uninsured Program
October 12, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
DOJ Fraud Division Issues Directive on Corporate Enforcement Strategy
October 5, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
DOJ Revises Justice Manual to Strengthen False Claims Act Enforcement
September 28, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
Dompé Settles Anti-Kickback Allegations for $32 Million
September 21, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

News
Trunk Discusses Pharma Launch Strategies Amid MFN Drug Pricing Pressure
September 15, 2026
Stephanie Trunk

Life Sciences Industry Group Co-Leader Stephanie Trunk was quoted discussing how pharmaceutical manufacturers are responding to the Trump Administration’s Most Favored Nation (MFN) drug pricing initiative, which seeks to align US drug prices more closely with lower prices charged in certain foreign markets.

Investigations Blog
DC Circuit Agrees Vertex Pharmaceuticals’ Fertility Support Program Would Violate Anti-Kickback Statute
September 14, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
SEC and FDA Enter Three-Year Memorandum of Understanding to Strengthen Enforcement Cooperation
September 8, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Investigations Blog
DOJ Announces the Launch of the National Fraud Detection Center
August 31, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Alerts
2(b) or Not 2(b): FDA Releases New Guidance on Determining Whether to Submit an ANDA or 505(b)(2)
August 27, 2026
Kevin M. Nelson

“Whether ‘tis nobler to deviate from the RLD and rely on established data, or take arms against a sea of troubles with a bioequivalent product that conforms to the sameness requirement — that is the question.” That might have been Shakespeare’s opening to Hamlet, had the Bard traded quills for regulatory submissions and Denmark for the District of Delaware or New Jersey.

Investigations Blog
DOJ Formally Establishes National Fraud Enforcement Division, Reassigns Criminal Division Portfolio
August 24, 2026
D. Jacques Smith + 6

Headlines that Matter for Companies and Executives in Regulated Industries

Press Release
Forghany Recognized by Benchmark Litigation’s ‘40 & Under List’
August 19, 2026

ArentFox Schiff is pleased to announce that Partner Ehsun Forghany has been named to Benchmark Litigation’s 40 & Under List, recognizing him amongst the “best and brightest litigators across the US.”

Investigations Blog
DOJ’s National Fraud Enforcement Division Announces Enforcement Priorities
August 17, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Press Release
Managing IP Names ArentFox Schiff and 17 Attorneys Among 2026 IP STARS
August 11, 2026

ArentFox Schiff is pleased to announce that Managing IP has listed 17 attorneys among the 2026 IP STARS, recognizing them as leaders in their firm and jurisdiction.

Investigations Blog
NYSBA Issues Ethics Opinion on Lawyer Involvement in Deceptive Investigative Conduct in FCA Cases
August 10, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

News
Prero Quoted on Extension Request for PFAS Data Reporting
August 4, 2026
Judah Prero

Counsel Judah Prero was quoted on the Minnesota Chamber of Commerce’s request to state regulators to delay reporting requirements for products containing per- and polyfluoroalkyl substances (PFAS).

Longevity Lens
Altered States, Standard Rules: FDA Finalizes Guidance on Psychedelic Drug Clinical Trials
August 3, 2026
Hillary M. Stemple + 2

On July 14, the US Food and Drug Administration (FDA) announced final guidance regarding clinical investigations of psychedelic drugs.

Investigations Blog
DOJ Declines to Prosecute Eye Care Management Company Under New Corporate Enforcement Policy; Founder Indicted for Fraud and Kickbacks
August 3, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Alerts
The (Pep)Tides Turn: FDA Panel Recommends Six of Seven for Compounding
July 31, 2026
Abha Kundi + 3

The Pharmacy Compounding Advisory Committee (PCAC) is a 14-member US Food and Drug Administration (FDA) advisory panel of pharmacists, physicians, and other experts. It reviews the scientific and safety record for bulk drug substances nominated for compounding and votes on non-binding recommendations to the FDA.

Customs & Import Compliance Blog
As the (Customs and Trade) World Turns: July 2026
July 28, 2026
Angela M. Santos + 15

Welcome to the July 2026 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.

Alerts
2027 Physician Fee Schedule Proposed Rule: CMS Proposes Mandatory 340B Claims Data Reporting
July 27, 2026
Stephanie Trunk + 1

On July 16, the Centers for Medicare & Medicaid Services (CMS) published the 2027 Physician Fee Schedule (PFS) proposed rule. Among other provisions, CMS has now proposed to convert a previously voluntary filing to a mandatory submission: requiring 340B Covered Entities to submit Part D claims data to the Medicare Part D Claims Data 340B Repository beginning in 2027.

Investigations Blog
NeoGenomics Laboratories to Pay $9.8 Million to Resolve FCA Allegations Relating to Below-Fair-Market-Value Consulting Services
July 27, 2026
D. Jacques Smith + 7

Headlines that Matter for Companies and Executives in Regulated Industries

Press Release
Three Partners and Firm Shortlisted for LMG Life Sciences Awards
July 20, 2026

ArentFox Schiff is pleased to announce that the firm and three partners have been shortlisted for the annual LMG Life Sciences Americas Awards.

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