News & Analysis as of

Compliance Regulatory Agencies Risk Management

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 -
Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

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On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

DLA Piper

Eight Considerations for Businesses Facing Corruption Checks by Thai Regulators

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In response to the significant worldwide issue of corruption, Thailand has implemented a comprehensive legal framework designed to promote transparency and accountability across both the public and private sectors....more

Husch Blackwell LLP

Clinical Trial Audit Readiness: A Step-by-Step Guide for Research Sites

Husch Blackwell LLP on

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...more

Guidepost Solutions LLC

Monitoring Against Whistleblower Retaliation

Guidepost Solutions LLC on

Saves Lives, Prevents Major Crimes, and Accelerates Voluntary Self - Disclosures The U.S. Department of Justice (“DoJ”) recently spotlighted its Whistleblower Awards Program and Voluntary Self Disclosure (“VSDs”)...more

Venable LLP

Marijuana Banking in 2022: Lessons Learned and Best Practices

Venable LLP on

​​​​​​​As we pass the halfway mark of 2022, it's a good time to reflect on what has happened, or not happened, with respect to the legal framework for the provision of financial services to marijuana-related businesses...more

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - June 1st - 3rd

Due to the COVID-19 pandemic, our Research Compliance Conference will be held virtually. Attendees will enjoy Research compliance sessions and industry updates in an interactive, online experience, plus have the opportunity...more

Hinshaw & Culbertson - Consumer Crossroads

NYDFS Issues Order and Instructions to Regulated Entities in Response to COVID-19

In response to challenges facing the financial services industry as a result of coronavirus (COVID-19), New York's Department of Financial Services (DFS) has issued a COVID-19 compliance order, along with a series of industry...more

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