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AI Drug Development: FDA Releases Draft Guidance

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Technology Trends in Manufacturing and Associated Legal Risk Management: Driving Technological Advancement with an Ecosystem View 

The importance of building technology-driven manufacturing businesses with an ecosystem focus—i.e., a comprehensive view of the complex network of suppliers, partners, and customers in a market—emerged as a critical theme for...more

Leveraging Risk Management Frameworks for AI Solutions in Health Care

As recently described by The New England Journal of Medicine, the liability risks associated with using artificial intelligence (AI) in a health care setting are substantial and have caused consternation among sector...more

Structuring IP Licenses to Manage Supply Chain Risks in the Automotive Industry

In recent years unexpected supply chain disruptions made it difficult for some automotive suppliers to manufacture components needed to fulfill their downstream orders on time and on budget. Although looking to alternate...more

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