CBER Director Focuses on Flexibility to Advance Regenerative Medicines
By Michael Mezher -
Published 08 May 2017
Peter Marks, director of the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) on Thursday said his office is equipped to support the development of cutting edge treatments, such as cell and gene therapies.
Categories: News, US, CBER, Biologics and biotechnology, Human cell and tissue, Regulatory strategy
Tags: Regenerative Medicine, Cell and Gene Therapy, Advanced Therapies, RMAT Designation
Humacyte Receives First of FDA’s Regenerative Medicine Designations
By Zachary Brennan -
Published 20 March 2017
The US Food and Drug Administration (FDA) on Monday offered one of its first Regenerative Medicine Advanced Therapy (RMAT) designations to Humacyte’s investigational human acellular vessel (HAV) Humacyl.
Categories: News, US, CBER, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy
Tags: RMAT designation, regenerative medicine, 21st Century Cures