ARTICLE | Regulation
Monoconal cocktails and panels defined
August 8, 1994 7:00 AM UTC
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...