WASHINGTON -- In a bid to reduce the wait for drug approvalfor a critical class of drugs, the Food and Drug Administrationhas eliminated a review layer in the approval process forcancer drugs.

The director of the FDA's Division of Oncology and PulmonaryDrug Products is now authorized to "sign off on action lettersfor NDAs (new drug applications) for all remaining undelegatedoncologic drug products, including new chemical entities,"according to an FDA memorandum.

The decentralization of authority eliminates several layers ofFDA bureaucracy and could reduce the time needed to fulfillthe approval process by up to a third, according to an FDAofficial. Further streamlining of drug review and other FDAprocedures is expected as the new FDA commissioner, DavidKessler, implements management reforms at the agency.

-- Steve Usdin BioWorld Washington Bureau

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