

fda-agency-news
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fda-agency-news posted a new post. 3 days ago
PRIVIGENFor the treatment of:
Primary humoral immunodeficiency (PI)
Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older
Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults -
fda-agency-news posted a new post. 4 days ago
Weaver Nut Company Inc., Issues Allergy Alert on Undeclared Milk in Chocolate NonpareilsWeaver Nut Company, Inc. is recalling the following chocolate products with specific lot codes, due to potential undeclared milk allergens. People who have an allergy or severe sensitivity to milk run the risk…
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fda-agency-news posted a new post. 4 days ago
Medtech Products Inc. Issues Nationwide Recall of Little Remedies® Honey Cough Syrup Due to Microbial ContaminationJune 17, 2025—Medtech Products Inc., a Prestige Consumer Healthcare Inc. company (“Medtech” or “Company”), is voluntarily recalling five lots of Little Remedies® Honey Cough Syrup (the “Product”) due to the…
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fda-agency-news posted a new post. 4 days ago
Xenotransplantation GuidancesThis page contains a listing of xenotransplantation guidances.
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fda-agency-news posted a new post. 4 days ago
Vaccine and Related Biological Product GuidancesThis page contains a listing of vaccine and related biological product guidances
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fda-agency-news posted a new post. 4 days ago
Cellular & Gene Therapy GuidancesThis page contains a listing of cellular and gene therapy guidances.
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fda-agency-news posted a new post. 4 days ago
Blood GuidancesThis page contains a listing of Blood Guidances guidances.
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fda-agency-news posted a new post. 4 days ago
Allergenics GuidancesThis page contains a listing of Allergenics Guidance documents.
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fda-agency-news posted a new post. a week ago
Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic AssaysLinks to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.
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fda-agency-news posted a new post. a week ago
Testing Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and DiseasesTesting HCT/P Donors for Relevant Communicable Diseases
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