Monday, October 30, 1995
WASHINGTON — The FDA is planning a significant reform of procedures that would streamline approvals for biologics products by eliminating establishment license (ELA) and lot release requirements and by creating a unified process for applying for approval of well-characterized biologics and drugs.
In addition, while not abandoning the biologics-drug division within the agency, the proposals would institute a common product application form for both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
Good manufacturing practices (GMP) inspections, similar to those used for drug products, would replace ELA procedures, while the agency simply would abandon the practice of requiring inspection of each lot of biologic therapeutics prior to release.
The agency has drafted an initial
definition of a well-characterized therapeutic involving recombinant DNA or
monoclonal antibody technology, and is planning a public workshop in December to
discuss the characterization issue more fully.
The proposed administrative changes are a relatively non-controversial subset of the comprehensive FDA reform packages drafted by BIO and other industry groups. They also mirror provisions of the draft FDA reform proposal circulated by Sen. Nancy Kassebaum, R-Kan., who heads the