What’s New
We share news about new product features, our thoughts on recent developments at MedaSystems or in the industry at large. Scroll down for a chronological view, or jump to posts using the categories to the left.
Expanded Access Is Not Informal: Lessons from a Recent FDA Warning Letter
In a recent FDA warning letter involving investigational distribution practices, the agency cited failures tied to regulatory authorization and documentation requirements. The specific facts are unique to that company, but the broader lesson applies to every emerging biotech developing an investigational product.