CBER hears calls for change

WASHINGTON - Representatives of the biotech industry told FDA officials last week that the time to overhaul the biologics regulatory process is now. They suggested that the current system is too slow in approving new products and so cumbersome that it is difficult for companies to make needed changes in manufacturing processes.

Allan Goldhammer, director of technical affairs for the Biotechnology Industry Organizaton, said that BIO had initiated reform discussions with FDA's Center for Biologics Evaluation and Research (CBER) in 1991. "Four years is too long for the rule-making process," Goldhammer said. Changes "need to be put on a fast track."...