FDA BIOLOGICAL LOT RELEASE COULD BE HANDLED BY OUTSIDE GROUPS, BIO SAYS; PhRMA DEFINES "BROAD PRINCIPLES" OF FDA REFORM; HIMA WANTS OPTIONAL OUTSIDE REVIEWS
Executive Summary
BIO believes FDA could outsource activities in the areas of lot inspections and lot release for biologicals, according to discussions by the association preliminary to development of FDA reform proposals. The Biotechnology Industry Organization board reviewed a series of memos suggesting FDA reforms at its Feb. 8 meeting.