Revlimid Lax Teratogenicity Studies Led To Broad Risk Management Plan – FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
An inadequate reproductive safety assessment of Celgene’s Revlimid was of central concern to FDA during its review of the myelodysplastic syndromes treatment and helped guide post-approval risk management requirements, review documents show.
You may also be interested in...
Revlimid Fast Track Status Based On Randomized Trial Plan Later Skipped
Celgene was granted a fast track designation for Revlimid based on plans to conduct a randomized trial that it later put off until after FDA approval, review documents show
FDA’s 2005 New Molecular Entity Total: 18, Including Five In December
FDA clearance of Bayer/Onyx’ Nexavar oncologic Dec. 20, ahead of its Jan. 11, 2006 user fee goal date, helped the agency achieve a total of 18 new molecular entity approvals in 2005.
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