"Priority" Review Slow Down: The Prasugrel Delay
This article was originally published in RPM Report
FDA is looking at a February advisory committee for the Lilly/Daiichi anti-clotting drug. That would put the review of the "priority" application at 14 months and counting. What does prasugrel mean for the priority review process?
You may also be interested in...
Biotech Stocks and Advisory Committees: No News Is Good News?
FDA has approved six new molecules already in 2012--and five were approved without going to an advisory committee. Meanwhile, FDA has held four advisory committees to review new drug applications, and all four ended in overwhelming "no" votes.
Going Back to a New Approach: FDA, Outside Experts, and Conflicts of Interest
FDA has gone far-maybe too far-in excluding outside experts from advisory committee panels who have potential conflicts of interest. The agency is considering easing back the restrictions. What will it mean for future external guidance to FDA?
Treat and Trade: The New Priority Review Voucher Market
Starting in September, pharmaceutical companies will have the opportunity to buy the right to a faster FDA review on the open market. If it works, the priority review voucher program could revolutionize development of drugs for neglected diseases, while increasing the value of more traditional commercial products in the US.