News & Analysis as of

Pharmaceutical Industry Risk Management

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - October 6th - 9th, San Antonio, TX

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Woodruff Sawyer

Insuring Global Clinical Trials: Navigating Risks Across Borders

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In part three of our three-part webinar series on Risk Management for Your Life Sciences Company, we focus on insurance for foreign clinical trials and provide updates on the clinical trial requirements of various countries....more

Snell & Wilmer

Securities Class Action Litigation Surges in Dollar Value Despite Steady Filing Numbers

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Cornerstone Research recently published its Securities Class Action Filings—2025 Mid-Year Assessment. The report contains useful data and information about the securities class action landscape thus far this year. The...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - September 8th - 11th, Scottsdale, AZ

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Fenwick & West LLP

10 Critical Missteps to Avoid When Building AI Governance Policies for Life Sciences Companies

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Life sciences companies racing to harness artificial intelligence often stumble into preventable traps that can derail innovation and create lasting legal exposure. ...more

Thomas Fox - Compliance Evangelist

AI Today in 5: August 11, 2025, The ACHILLES Project Episode

Welcome to AI Today in 5, the newest addition to the Compliance Podcast Network. Each day, Tom Fox will bring you 5 stories about AI to start your day. Sit back, enjoy a cup of morning coffee, and listen in to the AI Today In...more

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

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Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Hogan Lovells

China’s healthcare compliance guidelines: insights and actionable steps for life sciences companies

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In January 2025, China’s State Administration for Market Regulation (“SAMR”) introduced the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Guidelines”), marking the first...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

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Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

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

Hogan Lovells

Medicines shortages under the EU pharma law package

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The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: IP Litigation and Trials

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the tenth episode of When Your Life Sciences Are on the...more

American Conference Institute (ACI)

[Virtual Conference] Inaugural Summit on GLP-1 Law & Policy - July 24th, 8:15 am - 5:15 pm ET

The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more

Thomas Fox - Compliance Evangelist

Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition

Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance, brings you compliance-related stories to start your day. Sit back, enjoy a cup of morning coffee, and listen in to the Daily Compliance News....more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Morris James LLP

Analyzing the Impact of Recent Studies Linking Depo-Provera to Increased Meningioma Risk

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Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Troutman Pepper Locke

Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation...

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In this episode of Troutman Pepper Locke's Employee Benefits and Executive Compensation podcast, hosts Lydia Parker and Lynne Wakefield explore the complex legal landscape surrounding the coverage of GLP-1s prescribed for...more

Woodruff Sawyer

Cargo Stock Throughput Insurance for Life Science Companies

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In the dynamic world of life sciences, companies face unique challenges in safeguarding their valuable assets. From pharmaceuticals to biologics, medical devices to vaccines, these products often require specialized handling...more

Gardner Law

Staying Prepared Amid FDA Changes

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Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory enforcement. On the contrary, the...more

Gardner Law

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

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Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

Dentons

Ep. 63 – Speaking Fees and Safe Harbors: Lessons from a $202M AKS Settlement

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In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more

Hogan Lovells

AI Summit panelists weigh emerging data & privacy risks for novel technology

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Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including data and privacy...more

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