President signs FDA Safety & Innovation Act into law
President Obama has signed the Food and Drug Administration Safety and Innovation Act, which includes PDUFA, into law. From the White House:
S. 3187, the “Food and Drug Administration Safety and Innovation Act,” which reauthorizes a number of FDA user fee programs, including the Prescription Drug User Fee Act and Medical Device User Fee and Modernization Act, and increases FDA’s ability to provide timely and expedited review and approval of applications for prescription drugs and medical devices; authorizes new user fee programs for generic drugs and biosimilar biological products; extends and modifies FDA authorities related to drugs intended for use by children; and improves the drug approval process and helps to reduce drug shortages.
As we wrote about here, AstraZeneca hopes that the law will lead to a more efficient, predictable, transparent and well coordinated drug review process within the FDA while strengthening the scientific base at the agency, supporting patient safety and promoting innovation.