12:00 AM
Nov 12, 2001
 |  BioCentury  |  Politics, Policy & Law

FDA plans to manage drug risk

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).
Galson, who joined CDER in April, has devoted much of his career to risk management....

Read the full 472 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >