FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
I recently had the privilege of both presenting at and attending the 2021 Alliance for Regenerative Medicine (ARM) Annual Cell
Cell and gene therapy’s popularity has grown exponentially in the past year. However, it’s important to understand how cell and gene therapy research is different from traditional drug development.