FDA Advisory Panels Off To Slow Start In 2007 After Role Change In 2006
FDA is on pace to hold fewer advisory committee meetings in 2007 than in 2006
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Accelerated approval based on response rate is not appropriate for Genta's Genasense given the Bcl-2 inhibitor's failure to show a benefit on clinical outcomes in a randomized Phase III trial, FDA and members of its Oncologic Drugs Advisory Committee said during a Sept. 6 meeting
FDA's approval of Lilly's Gemzar to treat ovarian cancer - contrary to the advice of its Oncologic Drugs Advisory Committee - demonstrates the agency's willingness to accept progression-free survival as a clinically meaningful endpoint
Cellegy's Cellegesic for anal fissures may or may not need a new study for approval following a split decision by FDA's Cardiovascular and Renal Drugs Advisory Committee at its April 25 meeting