WASHINGTON -- FDA Commissioner David Kessler on Thursdayunveiled initiatives designed to speed the review of new drugapplications through the Center for Biologics Evaluation andResearch, including the appointment of Kathryn Zoon asdirector of the CBER.
In a speech to the Massachusetts Biotechnology Council, Kessleralso said the FDA plans to hire 50 research and review staff"for the sole attention of biotech products."
Kessler said that "FDA stands ready to fulfill our duty to reviewthese products quickly and to bring to the marketplace asmany safe and effective biotech products as can be developed."
In addition to Zoon's appointment, Kessler's announcementsincluded:
Surrogate Markers: As part of its efforts to streamline the drugreview process, the CBER will examine the use of criticalevaluation tools such as clinical end points and surrogatemarkers.
Drug Jurisdiction: A collaborative working agreement has beenimplemented between the Center for Biologics Evaluation andResearch and the Center for Drug Evaluation and Research,which provides for collaborative reviews when necessary.
It "spells out which center will have jurisdiction over theregulation of certain products, based upon product class, andfor combination products, based upon the primary mode ofaction," Kessler said.
Industry Liaison: An industry/CBER working group has beenestablished to review various manufacturing and licensingissues.
Dedicated Facilities: Six weeks ago the FDA broke ground for itsfirst building specifically dedicated to the evaluation of AIDStherapies and biotechnology products. It will give CBER and theFDA "state-of-the-art laboratories which (they) now lack,"according to Kessler.
Richard Godown, Industrial Biotechnology Associationpresident, said the 50 new research and review staff membershighlighted Kessler's commitment to biotechnology. "It isespecially significant because he had asked Congress for money(for the additional staff), and not getting it, he simply found it,took it from other places at FDA," said Godown. The currentstaff is about 150.
-- Steve Usdin BioWorld Washington Bureau
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