News & Analysis as of

Federal Pilot Programs

Apple, Fitbit Join Pilot Program to Quicken FDA Regulatory Review

by Knobbe Martens on

On September 26, 2017, the FDA announced that it has chosen nine tech companies to participate in a pilot program (FDA Pre-Cert) to help tech companies bypass some regulations that have hindered health software and products...more

IRS Opens Pilot Program on Tax-free Spin-offs

by Jones Day on

The Situation: In 2013, the IRS ceased issuing private letter rulings confirming the general tax consequences of tax-free spin-offs....more

The FCPA Compliance Defense — Don’t Wish for It, You Just Might Get It

by Michael Volkov on

Sometimes a bad idea just will not die. Sometime commentators like to return to simplistic solutions that sound good on paper. These same commentators have failed to address the practical concerns that outweigh any possible...more

CDRH's "Critical to Quality" PMA pilot program opens to applicants

by Hogan Lovells on

The voluntary PMA pilot program will run from September 29, 2017, to December 31, 2018, or until a total of nine PMA applicants have been enrolled. The program will engage these PMA applicants to identify and define device...more

IRS Expands Scope of Spin-Off Private Letter Rulings in 18-Month Pilot Program

by Shearman & Sterling LLP on

On September 21, 2017, the IRS announced in Revenue Procedure 2017-52 (the “Pilot Program Rev. Proc.”) that it is expanding the scope of spin-off private letter ruling requests that it will consider. The pilot program is...more

IRS Resumes Issuing Transactional Spin-Off Rulings

by Proskauer - Tax Talks on

On September 21, 2017, the Internal Revenue Service (the “IRS”) issued Revenue Procedure 2017-52 (the “Rev. Proc.”), introducing an 18-month “pilot program” in respect of corporate “spin-off,” “split-up” and “split-off”...more

China Introduces a New Class of Non-Truck-Owning-Carriers to Reduce Logistics Cost and Improve Efficiency

by Garvey Schubert Barer on

In line with PRC’s 13th Five-Year-Plan and “Internet+” initiative, the Ministry of Transport (MOT) launched the Non-Truck-Owning-Carrier program as a one-year pilot beginning December 2016. The goal of the program is to...more

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

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

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