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Compliance New Guidance Prescription Drugs

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 -
ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

ArentFox Schiff on

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

McDermott Will & Emery

After Almost 25 Years, FTC Issues New Health Products Compliance Guidance

McDermott Will & Emery on

The Federal Trade Commission (FTC) announced its Health Products Compliance Guidance on December 20, 2022. The 2022 guidance updates and replaces the FTC’s 1998 guidance, Dietary Supplements: An Advertising Guide for...more

Venable LLP

FTC Announces Health Products Compliance Guidance

Venable LLP on

On December 20th, 2022, the Federal Trade Commission published new guidance regarding claims about the benefits and safety of health-related products: Health Products Compliance Guidance. This guidance replaces the...more

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