FDA Rewrites Rules on Biologics

In a move designed to speed approval of new biotech products, the US Food & Drug Administration has transferred oversight for many new biotech therapies from its office that reviews biologics to the one that approves traditional drugs. Biotech and pharmaceutical companies had been pushing for the change for years, because it's generally believed that companies can more easily get regulatory clearance from the drug review section of the agency. This change became a reality with the arriva

Susan Warner
Jul 27, 2003

In a move designed to speed approval of new biotech products, the US Food & Drug Administration has transferred oversight for many new biotech therapies from its office that reviews biologics to the one that approves traditional drugs. Biotech and pharmaceutical companies had been pushing for the change for years, because it's generally believed that companies can more easily get regulatory clearance from the drug review section of the agency.

This change became a reality with the arrival of a new, aggressive FDA commissioner appointed by a more proindustry president. Adding to the momentum was last summer's ImClone scandal, which pointed to different procedures in the FDA's two review centers.

FDA officials have worked swiftly to reorganize and are attempting to make the transition as smooth as possible for products already in the process of review and for those ready for review. But others warn that the reorganization may actually...

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