News & Analysis as of

Artificial Intelligence Patents Food and Drug Administration (FDA)

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

Mintz - Intellectual Property Viewpoints

Patenting AI/ML Life Sciences and TechBio Innovations – How Much Disclosure is Sufficient?

In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

American Conference Institute (ACI)

[Event] The National Forum on IP Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies - March 21st -...

Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more

Foley & Lardner LLP

Top Legal Issues Facing the Manufacturing Sector in 2022

Foley & Lardner LLP on

As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more

Mintz

COVID-19: Prioritized Patent Application Examination and Patents 4 Partnerships

Mintz on

The United States Patent and Trademark Office (USPTO) has recently launched two new initiatives to support COVID-19 innovations: 1) a COVID-19 Prioritized Examination Pilot Program, and 2) Patents 4 Partnerships that provides...more

McDonnell Boehnen Hulbert & Berghoff LLP

Beyond Patents - FDA Regulatory Approval of Medical Devices and the Software Precertification Program

Artificial Intelligence (AI) and Machine Learning (ML) are poised to revolutionize the field of healthcare. For example, researchers are leveraging deep learning methods to find new ways to efficiently diagnose and treat...more

Mintz - Health Care Viewpoints

Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation

Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers? This post, the second in our blog...more

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