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Cynthia Schnedar, director of CDER’s Office of Compliance, is leaving to pursue opportunities in the private sector, Janet Woodcock said Monday in an emailed message. Her last day will be March 18. Read More
The FTC is arguing that a district court erred in failing to apply the Supreme Court ruling in FTC v. Actavis in a pay-for-delay case involving GlaxoSmithKline’s Wellbutrin XL antidepressant. Read More
Greater transparency of pharmaceutical pricing is the key to reducing the nation’s prescription drug tab, according to multiple comments sent to the Senate Finance Committee. Read More
Participation in biosimilar development program activities with the FDA has seen a steady uptick over the past three fiscal years — from 33 in fiscal 2013, to 57 last year — according to an analysis by independent consulting firm Eastern Research Group. Read More
The average cost of developing a new drug continues to rise, even as approval success rates continue to fall, according to a report that pegs the cost of ushering a candidate through FDA approval at an eye-popping $2.6 billion. Read More
Makers of protein-based biologics approved under the NDA pathway will lose all exclusivity rights in four years, and any NDA or ANDA that hasn’t been approved by March 23, 2020, will be voided. Read More