Beaver Street Fisheries, LLC of Jacksonville, FL is voluntarily recalling a limited quantity of Great Value Frozen Raw Shrimp EZ-Peel & Deveined Tail-On 21-25 Per lb as a precautionary measure per the recommended action stated in an FDA advisory statement dated 08/19/25 regarding Cesium-137 (Cs-137)
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This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.Peterson Company Recalls Twin Sisters Creamery Brand Whatcom Blue and Farmhouse Cheese Products Because of Possible Health Risk
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Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/22/2025
Short Title (70 char) Nephron Sc Inc. West Columbia, SC. 483 issued 08/22/2025
FEI Number 3010892830
Firm Name Nephron Sc Inc
Record Type 483
State SC
Establishment Type Sterile Drug ManufacturingFusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Los Angeles, CA. Amended 483 issued 12/20/2019
Task Description Request Please post to the ORA Electronic Reading Room
Record Date 12/20/2019
Short Title (70 char) Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Los Angeles, CA. Amended 483 issued 12/20/2019
FEI Number 3013341563
Firm Name Fusion IV Pharmaceuticals, Inc.
Record Type AmeScientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.
