Binh Nguyen

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 you 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...

How many of you use "human errors" as a reason of root cause in your conclusion of an investigation? A. Per Human error - Wikipedia : it...