An Inside Look At The REMS Review Process
This article was originally published in Pharmaceutical Approvals Monthly
You may also be interested in...
Drug Safety’s “Equal Voice” To Be Considered At Internal CDER Workshop
Review staff from the Center for Drug Evaluation and Research will meet in December to discuss how to implement the concept of giving an "equal voice" to safety personnel during regulatory decision-making
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
Provenge Paradox Sparks New Thinking About Immunotherapy Trials, Clinical Care
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