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Department of Justice (DOJ) Pharmaceutical Industry Compliance

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

K&L Gates LLP

The False Claims Act and Health Care: 2023 Recoveries and 2024 Outlook

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On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - May 9th - 10th, San Juan, Puerto Rico

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Akin Gump Strauss Hauer & Feld LLP

2024 Guide to DOJ and HHS OIG Guidance on Effective Compliance Programs

The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...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

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - December 2024

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

The Volkov Law Group

Justice Department Declines FCPA Prosecution Against Lifecore Biomedical Under Corporate Enforcement Policy

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The Justice Department has brought three corporate FCPA enforcement actions in 2023 (if you include the Ericsson DPA breach settlement).  With its recent announcement of a declination under the Corporate Enforcement Policy,...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Bass, Berry & Sims PLC

[Virtual Conference] Nashville Healthcare Fraud Conference - December 15th - 16th, 8:00 am - 1:00 pm CST

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Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 6. In This Month’s E-News: June 2021

Report on Research Compliance 18, no. 6 (June 2021) - Clemson University is pushing back against recommendations by auditors for the National Science Foundation Office of Inspector General (OIG) that it repay $276,440,...more

McDermott Will & Emery

International Legal Highlights - May 2021

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Expect More Criminal Enforcement & What You Can Do To Minimize Your Risk - Antitrust cartel and related collusive scheme enforcement is poised to increase. Several factors support this: (1) the Antitrust Division (the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Navigating Relationships With Practice Support and Other Tech Vendors

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

Skadden, Arps, Slate, Meagher & Flom LLP

DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

Manatt, Phelps & Phillips, LLP

[Webinar] What’s Past Is Present: Key Regulatory Trends Impacting Health Care/Life Sciences - March 23rd, 3:00 pm - 4:00 pm ET

From Pricing to Compliance to Coordinated Care, a Wide Range of Critical Areas Saw Regulatory Changes in 2020 That Will Impact the Health Care and Life Sciences Industries in 2021—and Beyond. Find Out How Your Organization...more

American Conference Institute (ACI)

[Virtual Event] FCPA & Anti-Corruption for the Life Sciences Industry - April 14th, 10:00 am - 6:00 pm EDT

Virtual Forum on the FCPA & Anti-Corruption for the Life Sciences Industry will take place on April 14, 2021 (Eastern Daylight Time). This is the only practical, comprehensive anti-corruption event that is truly tailored to...more

White & Case LLP

Fraud and abuse risks in digital health: What tech companies need to know about healthcare enforcement - Part I

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Digital health is exciting, innovative and forward-looking. Investors have invested billions of dollars anticipating dividends from the next phase of the Big Data revolution: collecting and synthesizing millions of data...more

The Volkov Law Group

Too Big to be Accountable: The Big Case Dilemma

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Over the last twenty year (yes, 20 years), the Justice Department’s civil and criminal enforcement record has come under greater scrutiny.  Whether you call it “Too Big To Jail” or “Too Big to Fail,” questions continue to...more

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments For July 2020

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Virtual Regional Healthcare Compliance Conference - Indianapolis, IN - September 25th, 8:30 am - 4:30 pm EDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Health Care Compliance Association (HCCA)

Department of Justice fines pharmaceutical company

Compliance Today (August 2020) - On May 7, the Department of Justice’s Antitrust Division announced a deferred prosecution agreement, in which Apotex Corp. agreed to pay a $24.1 million criminal penalty for...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 4 – CIA Structural Requirements

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Arnall Golden Gregory LLP

CIA Imposes Requirements for Pharmaceutical Speaker Programs and Events

On July 1, 2020, the United States Department of Justice (DOJ) announced two settlements with Novartis Pharmaceuticals Corporation (“Novartis”), resolving allegations that the company had paid illegal kickbacks to physicians...more

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