News & Analysis as of

Federal Pilot Programs

AGG Food and Drug Newsletter - August 2017

by Arnall Golden Gregory LLP on

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

Department of Justice Pilot Program Will Focus on Opioid Fraud and Abuse

by Arnall Golden Gregory LLP on

On August 2, 2017, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit and a new Department of Justice (DOJ) data analytics program to combat opioid-related fraud and abuse. The...more

China’s Pilot Programmes Welcome Announced Launch of Emissions Trading System

by Latham & Watkins LLP on

Chinese policymakers have indicated that the country’s Emissions Trading System (ETS) — which will be the largest system of its kind globally and the centerpiece of Chinese climate change policy — is likely to launch in...more

New FDA Digital Health Program

by Holland & Knight LLP on

The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in the Federal Register, announcing a pilot program to evaluate a “new...more

US Food and Drug Administration’s New Digital Health Innovation Action Plan Details a Software Precertification Pilot Program

by McDermott Will & Emery on

In recognition that the traditional regulatory approach toward moderate to high risk medical devices is not well-suited for current digital health software products, the US Food and Drug Administration published a Digital...more

DOJ Issues Two Declinations in First Corporate FCPA Enforcement Actions of the Trump Administration

by Allen & Overy LLP on

Speed read - In June 2017, the U.S. Department of Justice (DOJ) issued two “Declinations with Disgorgement” under the DOJ’s Pilot Program. The declinations were received by U.S. subsidiaries of the Linde Group (Linde) and...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

Fourth Declination With Disgorgement Announced Under FCPA Pilot Program

by Shearman & Sterling LLP on

On June 30, 2017, the Department of Justice (“DOJ”) announced that it had declined to bring charges against and was closing its investigation into CDM Smith Inc. (“CDM”), a Boston-based engineering and construction group, for...more

Justice Department Resolves Two Cases Under FCPA Pilot Program

by Michael Volkov on

The Justice Department recently resolved two separate FCPA investigations under its Pilot Program. To be sure, DOJ’s resolution of these two matters reinforces the real and tangible benefits of its Pilot Program....more

A Second Superior Result – CDM Smith Obtains a Declination

by Thomas Fox on

Last week the Department of Justice (DOJ) issued its second Declination under the Sessions regime. Short with brevity, the matter nonetheless has some significant points for the compliance practitioner to help move their...more

This New Pilot Program Can Speed Up Discovery, Especially in Arizona and Illinois: eDiscovery Best Practices

by CloudNine on

At its meeting in September of 2016, the Judicial Conference of the United States approved a pilot program to test procedures requiring mandatory initial discovery before the commencement of party-directed discovery in civil...more

Has the FCPA changed the US business culture?

by Thomas Fox on

In the early 70’s the Lockheed corruption scandals came into light. Millions of dollars had been paid by the US aircraft corporation to public officials to guarantee contracts for military aircraft in Germany, Italy, Japan,...more

FDA Steps Up on Medical Device Innovation

by Mark Mansour on

At long last, FDA has the makings of a coherent and forward-thinking policy to address the widening gap between industry's ability to innovate and FDA's regulatory capacity. Consistent with the mandate of the 21st Century...more

FCPA: 2017 Mid-Year Review Webinar

by Bryan Cave on

Enforcement of the Foreign Corrupt Practices Act was a high priority for the Department of Justice and the Securities and Exchange Commission in 2016. There's interest in how the new administration could impact enforcement as...more

U.S. Supreme Court Indirectly Limits Important Component of DOJ’s FCPA Pilot Program

by McGuireWoods LLP on

On June 5, 2017, the U.S. Supreme Court unanimously held in Kokesh v. Securities and Exchange Commission, No. 16-529, that the SEC may not reach beyond the general five year statute of limitations period in order to obtain...more

Video Transcript - FCPA Pilot Program

by Ropes & Gray LLP on

The DOJ enacted the Pilot Program in early 2016. It was part of a long running effort by the DOJ to provide more transparency and consistency into how it addresses, investigates and resolves cases. It was also designed to...more

The Kokesh Decision – One Question Answered, Others Left Open

by Thomas Fox on

In the case of Kokesh v. SEC, the US Supreme Court held the profit disgorgements operate as a penalty under the Securities and Exchange Act of 1934, as amended. As such “any claim for disgorgement in an SEC enforcement action...more

FCPA Pilot Program

by Ropes & Gray LLP on

Ryan Rohlfsen, Ropes & Gray government enforcement partner, analyzes the first year of the U.S. Department of Justice’s FCPA Pilot Program. __ The DOJ enacted the Pilot Program in early 2016. It was part of a long...more

Mandatory Pilot Program Expedites Discovery Schedules for the Northern District of Illinois

by Jones Day on

Beginning June 1, 2017, the Northern District of Illinois will be participating in a three-year pilot project, known as the "Mandatory Initial Discovery Pilot Project," which will require the parties in civil cases to respond...more

The Stoic's Guide to Compliance

by Thomas Fox on

One thing about successful Chief Compliance Officers (CCOs) and other compliance practitioners is they can take in severe news, keep calm and carry on. In a keynote speech to the SCCE Compliance and Ethics Institute, Jenny...more

Maine tidal pilot project not seeking new license

by PretiFlaherty on

The holder of a federal pilot license for a Maine tidal energy project has told regulators that it does not intend to relicense the project beyond the pilot license's expiration in 2022, pointing to tidal current velocities...more

Transparency in FCPA Enforcement

by Michael Volkov on

We all value transparency as a general concept, especially when it comes to the government. In a real macro perspective, we fund the government and we demand that our government operate efficiently, effectively and ethically....more

Operationalizing Compliance: Part I – It All Starts with Pizza

by Thomas Fox on

With the release of their Evaluation of Corporate Compliance Programs (Evaluation) in February, the Department of Justice (DOJ) emphasized yet again the importance of actually doing compliance and not simply having a paper...more

The Foreign Corrupt Practices Act and the New Trump Administration: Your Top Ten Questions Answered

by Foley & Lardner LLP on

Since mid-2000s investigation of Siemens, and the resulting $800 million penalty for violations of the Foreign Corrupt Practices Act (FCPA), the FCPA has been an enforcement priority of the U.S. Government. Although a dip in...more

What is the Real Risk of an FCPA Enforcement Action?

by Michael Volkov on

When speaking to clients or potential clients, the question of risk of enforcement is the moose on the table. Sometimes, the question gets asked and other times, the subject is never discussed. To be fair, it is not an easy...more

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