Iressa Gets Narrowed Indication Instead Of Withdrawal: New Model For FDA?
Executive Summary
FDA's decision to narrow the indication for AstraZeneca's Iressa rather than withdraw the drug could be seen as a model for future products approved under Subpart H that fail in confirmatory trials
You may also be interested in...
Avastin’s Breast Cancer Claim: Will FDA’s Hamburg Take A Middle Road?
FDA Commissioner Margaret Hamburg faces a decision on the future of Avastin’s (bevacizumab) first-line metastatic breast cancer claim that may not be so cut and dried as the Oncologic Drugs Advisory Committee’s unanimous vote favoring the indication’s withdrawal suggests.
Avastin’s Breast Cancer Claim: Will FDA’s Hamburg Take A Middle Road?
FDA Commissioner Margaret Hamburg faces a decision on the future of Avastin’s (bevacizumab) first-line metastatic breast cancer claim that may not be so cut and dried as the Oncologic Drugs Advisory Committee’s unanimous vote favoring the indication’s withdrawal suggests.
Accelerated “De-proval”? FDA May Be Ready To Withdraw Subpart H Drug
FDA is moving towards potentially withdrawing, for the first time, a drug brought to market under the Subpart H accelerated approval mechanism