NORD Comments on PDUFA Draft
Every five years, the Prescription Drug User Fees Act (PDUFA) must be reauthorized. This Act provides funding to FDA that has generally been believed to improve patient safety and the speed with which potential new drugs are reviewed.
FDA recently released a draft document summarizing its position to date on the PDUFA reauthorization. NORD responded with a statement of support for the content related to rare diseases and orphan products on page 23 of the document.