News & Analysis as of

Life Sciences Self-Disclosure Requirements

Morrison & Foerster LLP

DOJ National Security Division Issues First-Ever Declination Under Voluntary Self-Disclosure Policy

On May 22, 2024, the Department of Justice’s (DOJ) National Security Division (NSD) announced its first-ever prosecution declination under its corporate voluntary self-disclosure (VSD) policy for sanctions and export controls...more

Goodwin

DOJ Renews Focus on Private Equity Amid Record False Claims Act Enforcement

Goodwin on

2023 was another record year for False Claims Act enforcement. On February 22, 2024, the U.S. Department of Justice (DOJ) announced that the federal government and whistleblowers were party to a record number of FCA...more

American Conference Institute (ACI)

Practical Implications of the Department of Justice’s M&A Safe Harbor Policy

In early October 2023, Deputy Attorney General (DAG) Lisa Monaco announced a “new” (but not new) Department of Justice (DoJ) policy intended to incentivize acquiring companies to voluntarily self-disclose criminal misconduct...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – January 2024

This issue features articles on the firm’s Business Advisory Practice supporting Nervosave Therapeutics’ U.S. expansion; the USPTO’s forthcoming guidance on AI innovation protection; option pool sizes for life sciences...more

Morgan Lewis

US Government Enforcement: Focus on Asian Life Sciences Companies

Morgan Lewis on

The US Department of Justice (DOJ) has shown increased interest in enforcing the Foreign Corrupt Practices Act (FCPA) in the life sciences sector. The FCPA prohibits the payment of any kind of bribe, kickback, or thing of...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Regulation and Enforcement Updates

We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more

Paul Hastings LLP

New OIG Developments Provide Additional Avenues for Feedback and Compliance Guidance

Paul Hastings LLP on

In recent months, the Department of Health and Human Services, Office of Inspector General (“OIG” or “the agency”) announced two major developments in its effort to provide enhanced health care and life sciences industry...more

Seyfarth Shaw LLP

Employment Tips For The Pharmaceutical, Biotech, And Life Science Industries - Part 2

Seyfarth Shaw LLP on

Tip #2: Thorny Issues with Commissions Part 1: What Happens When a Salesperson Is Selling a Drug To Herself or Her Family Member? A key component of compensation for pharmaceutical salespeople is the sales commission, and...more

Hogan Lovells

Why Healthcare and Life Sciences Companies Need to Step Up Their Compliance Efforts in Advance of a U.S. Government Investigation

Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells partner Gejaa Gobena discusses how the perception of compliance, remediation, and self-disclosure has evolved in the eyes of government prosecutors from how they factor at...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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