Monoclonal cocktails and panels defined

WASHINGTON - The FDA's Center for Biologics Evaluation and Research (CBER) released a draft "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use."
The document presents "neither regulations nor guidelines, but serve(s) to represent current consensus" of CBER, according to a cover memo signed by Director Kathryn Zoon.
CBER "is open to proposals for clinical testing and licensing of combinations of mAb that are based on a preexisting pre-clinical evaluation and