Developing a cell or gene therapy (CGT) involves a range of regulatory considerations and challenges. Emily Marden and Jaclyn Fonteyne point to some key factors that are currently the focus of FDA attention and may merit consideration by sponsors early in the development process.
About Emily Marden
Entries by Emily Marden
FDA details its view of the “limitations” of single-arm trials in oncology drug development and invites comment on its favored approach going forward. Becky Wood, Emily Marden, and Julea Lipiz explain.
A new Executive Order in the U.S. aims to ease the path to market for products that use synthetic biology or genome editing. Emily Marden explains the thinking behind the announcement and its efforts to streamline the current U.S. framework for biotech.