Iressa Casts Shadow Over Zarnestra Advisory Committee Review
Executive Summary
The rejection of J&J's Zarnestra by an FDA advisory committee suggests that the failure of Iressa to demonstrate clinical benefit will have consequences for the next generation of oncology NDAs
You may also be interested in...
FDA Can Expand Access To Experimental Drugs, Without Compromising Trials
FDA would be able to maintain the integrity of rigorous clinical trials and permit increased access to experimental drugs through the use of better science, according to former FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb
FDA Can Expand Access To Experimental Drugs, Without Compromising Trials
FDA would be able to maintain the integrity of rigorous clinical trials and permit increased access to experimental drugs through the use of better science, according to former FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb
“Exceptional” Approval Could Replace “Accelerated” For Rare Cancer Drugs
An "exceptional" approval process should be carved out of the accelerated approval program for products targeting rare cancers where there is little likelihood of completing confirmatory trials, members of FDA's Oncologic Drugs Advisory Committee recommended