Binh Nguyen

Drug development has long been a complex, costly, and time-consuming process. Traditional methods often rely heavily on animal testing and lengthy clinical trials, which can delay the arrival of new treatments to patients. Today, new approach methodologies (NAMs) are reshaping how researchers discover and develop medicines. These methods use advanced technologies and alternative testing strategies to improve efficiency, reduce costs, and enhance safety assessments. Previously FDA Announces...

On December 08, 2025, FDA Qualifies First AI Drug Development Tool, Will Be Used in 'MASH' Clinical Trials | FDA . What does this mean for the industry? Is AI a tool to use in advancing drug approvals? Should you consider AI use in your space now that FDA has "qualified" the first AI tool? Does AI tool need to be validated before submitting to the FDA? It's important to note that in the Drug Development Tool Qualification Letter, the FDA emphasizes the following: "The tool is designed to...

So if you're a sunscreen OTC manufacturer, what regulations should you follow to prepare for FDA inspection? This depends on how your...