MCI Trials Should Test Diagnostic Criteria In Community Settings – FDA Cmte.
This article was originally published in Pharmaceutical Approvals Monthly
Pivotal studies to support a drug for treatment of mild cognitive impairment (MCI) should include a trial in a community-based setting, FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee agreed March 13.
You may also be interested in...
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class