CBER Updates Scientific Dispute Resolution Procedures

February 19, 2009
In an effort to keep scientific disputes from delaying regulatory decisions, the Center for Biologics Evaluation and Research (CBER) has updated its manual on dispute resolutions. Regulatory decisions on new products will continue to be made despite a scientific disagreement unless the argument concerns a possible risk to public health or a delay of the decision would not be critical, the manual says.
Devices & Diagnostics Letter