It is crucial to understand the drug development process and the many milestones and tasks that are essential to a comprehensive development plan to guarantee scientific and commercial success. While ...

The Regulatory Affairs for Cell and Gene Therapy post-baccalaureate certificate program trains leaders for this growing discipline and prepares them to bring new therapeutics to market. Students learn ...

In 2023, the FDA rejected a small pharmaceutical company's new drug application (NDA) with a Refusal-to-File (RTF) decision. This letter provided information on a range of issues within the submission ...