Day: November 6, 2025

Imagine dedicating years and millions of dollars to developing a life-changing new medicine, only to have its application refused by the FDA due to a preventable administrative error. This costly setback, the Refuse to File (RTF) action, consumes immense resources and delays promising treatments from reaching patients. The FDA RTF checklists used by its own … Read more

The federal government is in a funding lapse, a formal way of saying Congress didn’t pass a budget, and the government has “shut down.” If you’re a company developing a new medicine or device, you might assume the FDA’s doors are completely closed—but that is a critical misconception. While a shutdown does create significant regulatory … Read more