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Compliance Regulatory Requirements Product Defects

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 -
Gardner Law

Product Liability Prevention: A Proactive Approach for FDA-Regulated Industries

Gardner Law on

Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant...more

Morrison & Foerster LLP

CPSC’s 2024 Year in Review

In recent years, the Consumer Product Safety Commission (CPSC) has increased pressure on consumer product companies through various enforcement mechanisms. The increase in the frequency and amount of civil penalties sought by...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

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