Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint
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Biocon Sdn. – 8/30/2022. Country: Malaysia. Record Type: 483OMUFA Performance Reports
Over-the-Counter Monograph Drug User Fee annual performance reports to CongressSummary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT- Animal Model Qualification Program, DDT- Biomarker Qualification Program, DDT- Clinical Outcomes Assessment [COA] Qualification Program). Numbers are also provided byDenver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/11/2025
Short Title (70 char) Denver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
FEI Number 3013438582
Firm Name Denver Solutions, LLC
Record Type 483
State CO
Establishment Type Outsourcing FacilityAlert: Automated Impella Controller Correction due to Cybersecurity Issue from Abiomed
Abiomed has issued a letter to affected customers of cybersecurity vulnerabilities related to the operating system in the Automated Impella ControllerQuVa Pharma, Inc. Sugar Land, TX. Untitled Letter issued 06/18/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/18/2025
Short Title (70 char) QuVa Pharma, Inc. Sugar Land, TX. Untitled Letter issued 06/18/2025
FEI Number 3012053582
Firm Name QuVa Pharma, Inc
Record Type 483
State TX
Establishment Type Outsourcing Facil