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Pharmaceutical Industry › Food and Drug Administration (FDA) › Federal Contractors

Bass, Berry & Sims PLC

New Legislation Strengthens Disclosure Requirements for Potential Organizational Conflicts of Interest

Bass, Berry & Sims PLC on

On December 27, President Biden signed the Preventing Organizational Conflicts of Interest in Federal Acquisition Act into law. The legislation, ushered through Congress by a bipartisan group of backers, strengthens existing...more

McDermott Will & Emery

What the Latest Executive Order Means for Federal Contractors and FDA

McDermott Will & Emery on

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

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

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

Stinson - Government Contracting Matters

GAO Reminds Offerors that It’s Important to Substantiate Key Personnel’s Experience

Stinson - Government Contracting Matters on

Putting your best foot, or best personnel, forward seems like “Winning the Contract Award 101.” But a refresher course never hurts. Recently, the Government Accountability Office (GAO) decision in Deloitte Consulting, LLC...more

Troutman Pepper

Third Circuit Weighs in on Materiality for First Time Since Escobar

Troutman Pepper on

A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more

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