FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in the last few years and the unprecedented...more
The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more
The U.S. Food and Drug Administration (FDA) has announced the establishment of the “Center for Drug Evaluation (CDER) Center for Clinical Trial Innovation” (C3TI). C3TI is intended to be a “central hub” within CDER aimed at...more