GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality, and affordable generics.
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ask Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/14/2025
Short Title (70 char) OSRX Inc. Missoula, MT. 483 issued 11/14/2025
FEI Number 3014549846
Firm Name OSRX Inc
Record Type 483
State MT
Establishment Type Outsourcing Facility