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Enforcement Actions Imports Medical Devices

Gardner Law

What to Do When FDA Detains Your Shipment

Gardner Law on

When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more

Society of Corporate Compliance and Ethics...

A look at the EU Market Surveillance Regulation

Report on Supply Chain Compliance 3, no. 21 (October 29, 2020) - The European Union has some of the world’s most robust environmental, health and safety standards for products sold and imported into the market. Despite...more

Holland & Knight LLP

FinCEN Warns of Scams Relating to PPE and Other Medical Goods During COVID-19 Pandemic

Holland & Knight LLP on

In struggling to address the evolving COVID-19 pandemic, the United States and many other countries continue to face major shortages of Personal Protective Equipment (PPE), such as N95 masks, gowns and other vital materials...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

Baker Donelson on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

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