Avoiding and Reacting to Human Tissue, Cell, and Gene Therapy Enforcement Actions: Communication is Key
In the final two months of the calendar year 2019, FDA’s Center for Biologics Evaluation and Research (CBER) took compliance actions against human tissue, cell, and gene therapy manufacturers that included the issuance of Untitled Letters, Warning Letters, and an administrative action to cease manufacturing.These took place when the agency was in a period of […]