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Manufacturers Pharmaceutical Industry Federal Contractors

McDermott Will & Emery

What the Latest Executive Order Means for Federal Contractors and FDA

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The August 6, 2020, Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States directs the FDA and other federal agencies to take actions that could expand...more

McDermott Will & Emery

August 13, 2020, Deadline for Healthcare Providers and Life Sciences Federal Contractors: Ban on Use of Certain Chinese...

McDermott Will & Emery on

Effective August 13, 2020, an Interim Rule jointly issued by the Department of Defense (DoD), the General Services Administration (GSA), and the National Aeronautics and Space Administration (NASA) that amends the Federal...more

The Volkov Law Group

Drug and Medical Device Fraud Risks Increase in Pandemic Era

The Volkov Law Group on

The drug and medical device/testing industry is under significant pressure to develop new products to address the COVID-19 pandemic.  The federal government is increasing spending and support of drug and device companies in...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Changes the Game for Selling Single-API Drugs to the Government

Selling drugs to the Government just got a lot simpler. In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door to all drugs “manufactured”—that is, measured,...more

Sheppard Mullin Richter & Hampton LLP

What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance

On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020). In Acetris, the Federal Circuit was asked to...more

Morgan Lewis

Federal Circuit Acetris Decision Is Important for Pharmaceutical Manufacturers Planning Sales to US Government

Morgan Lewis on

The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue...more

McDermott Will & Emery

Cartel Snapshot - June 2019

McDermott Will & Emery on

The Department of Justice (DOJ) Antitrust Division announced three new investigations and several developments in its other investigations, including new investigations in the commercial flooring industry, online auctions for...more

Foley & Lardner LLP

Opportunities for Increased Drug Sales to the VA

Foley & Lardner LLP on

Pharmaceutical manufacturers that produce drugs in non-designated countries under the Trade Agreements Act (TAA) may now have an opportunity to increase their sales to the United States government. The Department of Veterans...more

Katten Muchin Rosenman LLP

The Sixth Circuit Reins in the Government's Measure of False Claims Act Damages

Pharmaceutical and device companies, financial institutions, government contractors, oil and gas conglomerates, and other public and private entities continue to be in the crosshairs of aggressive federal government...more

The Volkov Law Group

The FCPA Year in Review: Twist and Shout (Part I of II)

The Volkov Law Group on

We all like annual reviews and predictions for the upcoming year – it is a New Year’s rite of passage and one that brings perspective and a sense of order to our otherwise chaotic lives....more

King & Spalding

Recent False Claims Act Decision Provides Important Guidance To Manufacturers And Resellers About Trade Agreements Act Compliance

King & Spalding on

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court's dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

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