Call to Action. In a letter dated July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a clear call to action for manufacturers, distributors, and retailers of infant formula, baby food, and children’s food...more
On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions (AI-DFS) final...more
Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions.
This hot topic was...more
9/26/2024
/ Analytics ,
Artificial Intelligence ,
Best Practices ,
Compliance ,
Contract Terms ,
Due Diligence ,
Governance Standards ,
Health Care Providers ,
Healthcare ,
Information Security ,
Insurance Industry ,
Machine Learning ,
Medical Devices ,
Policies and Procedures ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Oversight ,
Reimbursements
If artificial intelligence (AI) is the vehicle that will revolutionize health care, data is the fuel that will propel the revolution. Health AI startups have recognized an unprecedented opportunity to create a transformative...more
9/15/2023
/ Artificial Intelligence ,
Change of Control ,
Collaboration ,
Contract Term ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Healthcare ,
Hospitals ,
License Renewals ,
Medical Devices ,
Pharmaceutical Industry ,
Pricing ,
Regulatory Requirements ,
Startups
Agility and resiliency remain essential attributes for manufacturers in 2023. Manufacturers are no longer focused on figuring out when things will return to “normal.”
Instead, they are applying lessons learned from the...more
7/11/2023
/ Artificial Intelligence ,
Best Practices ,
Clawbacks ,
Compensation ,
Compliance ,
Customs and Border Protection ,
Cyber Threats ,
Cybersecurity ,
Enforcement ,
Environmental Protection Agency (EPA) ,
Final Rules ,
Intellectual Property Protection ,
Machine Learning ,
Manufacturers ,
Securities and Exchange Commission (SEC) ,
Supply Chain
On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more
Welcome to issue two of Foley’s Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue, we will explore collaboration between the...more
7/12/2019
/ Artificial Intelligence ,
Big Data ,
Biotechnology ,
Blockchain ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Machine Learning ,
Manufacturers ,
Regulatory Agenda ,
Supply Chain ,
USDA