The U.S. Food and Drug Administration (FDA) has issued draft guidance on its “Platform Technology Designation Program,” which aims to streamline drug development, manufacturing, and marketing application review for products...more
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
Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which provides recommendations to...more
As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of...more
The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more
On June 29-30, 2022, the U.S. Food and Drug Administration (FDA) will hold a virtual public meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) to discuss its regulatory expectations for...more