BioCentury on BioBusiness,
Politics and Policy
FDA plans to manage drug risk
Monday, November 12, 2001
Stung by high profile withdrawals of drugs due to unexpected
toxicities, as well as an inability to get physician compliance with warning labels, FDA's
Center for Drug Evaluation and Research is reorganizing to emphasize risk management.
At a meeting of regulatory affairs professionals on the same day he was
named acting director of CDER, Steven Galson described proposed organizational changes.
Galston is temporarily taking over management of the center while Janet Woodcock leads an
initiative to revamp FDA's counter-terrorism capabilities (see BioCentury Extra,
Tuesday Nov. 6).
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