New legislation will be required for FDA to continue collecting biosimilar user fees in future fiscal years. Information related to FDA’s preparation for the third reauthorization of BsUFA will be hosted here on this page as it becomes available.
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Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 10/30/2025
Short Title (70 char) SCA Pharmaceuticals Inc. Little Rock, AR. 483 issued 10/30/2025
FEI Number 3010683157
Firm Name SCA Pharmaceuticals Inc
Record Type 483
State AR
Establishment Type Outsourcing FaReal-World Evidence Submissions to the Center for Drug Evaluation and Research
As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA VII), FDA committed to reporting aggregate and anonymized information on submissions.