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Food and Drug Administration Safety and Innovation Act (FDASIA)
The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, gives FDA the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development.
"Support for FDA user fees is a testament to the important role FDA plays in America’s healthcare continuum. FDA’s medical product decisions sit at the intersection of public health, innovation, and commerce and touch the lives of nearly every American every day," said FDA Commissioner Margaret A. Hamburg, M.D.
This is the fifth authorization of the Prescription Drug User Fee Act or PDUFA, first enacted in 1992, and the third authorization of the Medical Device User Fee Act, or MDUFA, first enacted in 2002. Both programs have provided steady and reliable funding to maintain and support a staff of trained reviewers who must determine whether a proposed new product is safe and effective for patients and do so within a certain time period. The new user fee programs for generic drugs and biosimilar biologics build on the successes of these two established user fee programs.
- Reauthorization of User Fees for Prescription Drugs Will Ensure a Predictable and Efficient Human Drug Review Program
- Medical Device User Fee Amendments of 2012
- New User Fees for Generic Drugs Will Enhance Americans’ Access to Less Expensive Drugs and Generate Major Cost Savings
- New "Biosimilars" User Fees Will Enhance Americans' Access to Alternatives to Biologic Drugs
- Pediatric Provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA)
- Drug Products in Shortage in the United States
- Increased Patient Participation in Medical Product Regulation
- Breakthrough Therapies