RMAT Designation Enables Critical Manufacturing Discussions

RMAT Designation Enables Critical Manufacturing Discussions – FDA's Marks

12 Sep 2017

Designation of cell and gene therapies as regenerative medicine advanced therapies is enabling deeper interaction with the US FDA on manufacturing challenges, says the head of the agency's biologics center.

The new regenerative medicine advanced therapy designation is turning out to offer a major benefit of deeper regulatory interactions around manufacturing issues, according to Peter Marks, director of FDA's Center for Biological Evaluation and Research.

Like the US breakthrough designation, RMAT offers early and frequent opportunities for exchanges with regulators, with the goal of quicker...