Blogging has taken a back seat to a whole bunch of legislative projects, meetings (attending and organizing), and membership recruitment efforts. Here is a bit of insight into a new piece of legislation we may be pushing forward with at NIO in the coming year.

Transferable Priority Review Vouchers for Severe and Neglected Brain Diseases: A priority review voucher is an incentive for companies to invest in new drugs and medical devices for severe and neglected diseases of the brain and nervous system. The legislation would authorize the FDA to award a transferable “priority review voucher” to the sponsor (manufacturer) of a newly approved drug, biologic or medical device that targets severe and neglected brain diseases. The provision applies to New Drug Applications (NDAs), Biological License Applications (BLAs), 505(b)(2) applications, Premarket Approval applications (PMA) and Premaket Notification 510(k) applications. The voucher, which is transferable and can be sold, entitles the bearer to a priority review for another product.