Capricor Eyes RMAT Designation Based On Interim Phase II Data

One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.

The guidance on post-market surveillance is one among a trio of new guidelines related to cell and gene therapies in the post-Peter Marks era.

New promotions and social media posts may offer some hints as to the philosophies guiding agency leaders. One CBER appointee stands out for her connections to Arnold Ventures.

While drug regulators are “conservative” by nature, the European Medicines Agency wants to help companies rather than rip their dossiers “into little pieces,” a senior regulatory assessor says.