Background on FDASIA
Fact Sheets, updates, and news on FDASIA implementation.
Fact Sheets
- 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 Americansâ 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
Resources
- FDASIA Implementation Tracking Chart (FDASIA-TRACK)
- Full text of the FDASIA law
- Blog: User Fees: Ensuring a Stronger and Better FDA