JD Supra

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI)[1] models in drug development and in regulatory submissions titled, ...
JD Supra

AI Drug Development: FDA Releases Draft Guidance

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and ...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

Simulations Plus Positioned to Capitalize on FDA’s Streamlined Nonclinical Safety Guidance with Advanced Mechanistic and Model-Informed Solutions

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- Simulations Plus, Inc. (SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances ...
Forbes

Adoption Of Model-Informed Drug Development Can Improve Pharma ROI

Inflation and the Covid-19 pandemic have put pharmaceutical productivity front and center in recent years. Thus, drug companies are under mounting pressure to prove that new treatments are safe and ...