FDA Transparency: Agency’s Hands Tied by its own Regulations
By Zachary Brennan -
Published 15 March 2017
Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality.
Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy
Tags: FDA transparency, CRLs, biosimilars