News & Analysis as of

Intellectual Property Protection Data Privacy Food and Drug Administration (FDA)

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

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

Husch Blackwell LLP on

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

Husch Blackwell LLP

Structuring the Right Deals for Growth in Life Sciences

Husch Blackwell LLP on

Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

Gardner Law on

The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

Gardner Law

Effective Clinical Trial Agreements: What You Need to Know

Gardner Law on

Clinical trial agreements (CTAs) form the foundation of any clinical research initiative, establishing the legal and operational framework essential for a study's success. Crafting, reviewing, and negotiating CTAs require...more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

American Conference Institute (ACI)

[Event] West Coast Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products - September 28th - 29th, Santa...

The American Conference Institute is hosting its first West Coast Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in Santa Monica on September 28-29, 2023! This conference comes just in time to...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

Ankura on

The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 3, Issue 5

The Cryptocurrency Revolution and President Biden's Formal Recognition - Out of the ashes of the 2008 financial crisis, Bitcoin sprang up like an insurgency, targeting both the unbridled activity of large financial...more

Morgan Lewis

Life Sciences International Review - Q2 2019

Morgan Lewis on

EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more

K&L Gates LLP

K&L Gates Triage: Artificial Intelligence in Health Care

K&L Gates LLP on

Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more

Mintz - Health Care Viewpoints

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

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