News & Analysis as of

Food and Drug Administration (FDA) Life Sciences Corporate Counsel

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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

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In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more

MoFo Life Sciences

The Legal And Regulatory Landscape Evolving With AI In Life Sciences

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In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

TransPerfect Legal

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

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In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...more

McDermott Will & Schulte

[Event] Life Sciences Boot Camp For In-House Counsel 2023 - April 4th, South San Francisco, CA

McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more

Hogan Lovells

(Patient) safety first: take steps now to promote good governance by your board

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Earlier this year, the Delaware Chancery Court approved a breathtaking $237.5 million settlement of derivative claims brought against Boeing’s board for breach of fiduciary duties regarding safety oversight. While the Boeing...more

Arnall Golden Gregory LLP

Get Back to Where You Once Belonged: FDA Issues Final Guidance on Initiating Voluntary Recall

In 1969, The Beatles told Jo Jo and Loretta to “get back to where you once belonged.” In 2021, we could view a documentary series by the same name about the recording sessions behind the classic Let It Be album. FDA officials...more

McDermott Will & Schulte

[Ongoing Program] Life Sciences Bootcamp Series - FDA and IP - May 25th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

McDermott Will & Schulte

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Consumer Protection and FDA - May 18th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

Hogan Lovells

Five highlights from FDA’s new AI device regulation Action Plan

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On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more

The Volkov Law Group

Delaware Court Increases Scrutiny of Corporate Board Oversight and Monitoring of Compliance Programs

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On October 1, 2019, in In re Clovis Oncology, Inc. Derivative Litigation, a Delaware Chancery Court denied a motion to dismiss the plaintiffs’ claims under the Caremark decision against individual directors for failing to...more

American Conference Institute (ACI)

[Event] Drug and Medical Device Litigation – the Must-Attend Event for the Life Sciences Products Liability Community - December...

Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more

Fenwick & West LLP

SEC Fines Life Sciences Company for Regulation FD Violations

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For the first time in six years, the U.S. Securities and Exchange Commission issued an enforcement action against a company solely for Regulation FD violations. On Aug. 20, the SEC announced that it charged life sciences...more

McDermott Will & Schulte

[Event] Life Sciences Bootcamp for In-House Counsel - May 14th, Lincolnshire, IL

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

McDermott Will & Schulte

[Event] 2019 Life Sciences Bootcamp for In-House Counsel - March 20th, Cambridge, MA

McDermott’s cross-functional team of life sciences professionals present the second annual Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more

Cooley LLP

Alert: Life Sciences Company Hit with $4 Million SEC Penalty

Cooley LLP on

On March 29, the US Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based pharmaceutical company, agreed to pay a $4 million penalty to settle fraud charges that it failed to...more

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