News & Analysis as of

Compliance Department of Justice (DOJ) Federal Food Drug and Cosmetic Act (FFDCA)

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Regulation and Enforcement Updates

We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more

Hogan Lovells

DOJ’s Consumer Protection Branch rolls out new voluntary self-disclosure policy

Hogan Lovells on

On March 3, 2023, the Consumer Protection Branch (CPB) of the Civil Division of the U.S. Department of Justice (DOJ) publicly released a new voluntary self-disclosure policy (“CPB VSD Policy”). The CPB VSD Policy seeks to...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Dechert LLP

U.S. Executive and Legislative Branches Raise the Heat on Slave Labor and Trade Law Violations

Dechert LLP on

Weeks ago, on September 14 2020, the Trump Administration made news by announcing a ban on the importation of certain products made in China’s Xinjiang region, where widespread human rights abuses—including slave labor work...more

The Volkov Law Group

DOJ Resolves Two Important Food Safety Criminal Cases: Blue Bell Creameries and Chipotle Mexican Grill (Part I of II)

The Volkov Law Group on

In an important set of criminal prosecutions for food safety violations, the Justice Department recently announced resolutions with Blue Bell Creameries and Chipotle Mexican Grill....more

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

King & Spalding on

Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more

The Volkov Law Group

Food Safety Criminal Prosecutions: When Compliance is a Matter of Life and Death

The Volkov Law Group on

Over the last ten to twenty years, we have witnessed the expansion of federal criminal prosecution of health and safety matters. Environmental and food and drug regulatory enforcement has been supplemented by aggressive...more

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