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Compliance Risk Management Life Sciences

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 -
White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Gardner Law

From Paper to Practice: Compliance Policies that Work

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In the FDA-regulated industry, a compliance program isn’t just a formality—it’s a critical tool for protecting your business, patients, and reputation. Still, too many companies treat compliance policies as static...more

Arnall Golden Gregory LLP

Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

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Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

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Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Gardner Law

Changes Proposed to HIPAA Security Rules

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On December 27, 2024, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule and strengthen cybersecurity protections for electronic protected...more

Hogan Lovells

MHRA publishes guidance on to new UK medical device post-market surveillance requirements

Hogan Lovells on

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Detailed Guidance for Biopharma Industry on What Information to Provide to FDA About Use of AI Models

On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more

MoFo Life Sciences

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety,...

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Latham & Watkins LLP

FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Latham & Watkins LLP on

The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more

Fenwick & West LLP

FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know

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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more

Gardner Law

Streamlining Device Changes with Predetermined Change Control Plans (PCCPs)

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In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more

Ropes & Gray LLP

New Year, New Data Breach Notification Requirements in New York: Impactful Changes for Life Sciences and Consumer Health Care...

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In December 2024, New York Governor Kathy Hochul signed into law two bills (A8872A and S2376B; collectively, the “Bills”) that amend New York’s Data Breach Notification Law. The Bills introduce a maximum thirty-day timeframe...more

Ropes & Gray LLP

DOJ Issues Final Rule Restricting Flow of Bulk Sensitive Personal Data to China and Other Countries of Concern

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On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States...more

Paul Hastings LLP

Compliance as the Catalyst: ESG in Life Sciences

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Like many companies in other sectors, Life Sciences companies recognize that corporate social responsibility (CSR)–evaluated and measured by independent rating organizations and based on their compliance with any applicable...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

American Conference Institute (ACI)

[Complimentary Webinar] Mitigating Sanctions and Export Control Risks for Life Sciences, Research Institutes and Universities -...

Global life sciences companies, research institutes, and universities face unique challenges when complying with U.S. and non-U.S. trade control laws, including complying with general and specific licenses authorizing...more

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

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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

McDermott Will & Schulte

[Event] Life Sciences Bootcamp for In-House Counsel - July 18th, San Francisco, CA

McDermott’s cross-functional team of life sciences professionals present the inaugural Bay-Area Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. ...more

Thomas Fox - Compliance Evangelist

Risk in Compliance Week: Part I – Forecasting

This week I will feature a series on risk in compliance where I will be joined by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment...more

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