• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
    Wednesday, July 2, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Links 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.
  • Fluzone and Fluzone High-Dose
    Wednesday, July 2, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Product approval information for Influenza Virus Vaccine
  • What’s New for Biologics
    Wednesday, July 2, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Latest news from the Center for Biologics Evaluation and Research
  • Recently Issued Guidance Documents
    Wednesday, July 2, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This page lists Recently Issued CBER and Cross-Center Guidance Documents.
  • Administrative Guidances
    Wednesday, July 2, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This page lists Administrative Guidance documents.
  • Biologics Electronic Reading Room (eFOIA)
    Tuesday, July 1, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.
  • FLUCELVAX
    Tuesday, July 1, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
  • FluMist
    Tuesday, July 1, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    For the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
  • Biologics PREA Reviews and Labeling Changes
    Tuesday, July 1, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)....
  • InVia Fertility Specialists, PLLC - 710632 - 06/13/2025
    Tuesday, July 1, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
  • FDA Rare Disease Innovation Hub
    Tuesday, July 1, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
  • FDA 483, dated June 11, 2008, (9 pages)
    Monday, June 30, 2025 from ORA Reading Room RSS Feed
    FDA 483, dated June 11, 2008, (9 pages)
  • GAMMAGARD LIQUID
    Monday, June 30, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Product approval information is indicated for: • Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. • Maintenance therapy to improve muscle strength and disability in...
  • TECARTUS
    Monday, June 30, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    For the treatment of adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL). For the treatment of adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL).
  • YESCARTA
    Monday, June 30, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the...
  • Conducting Remote Regulatory Assessments Questions and Answers
    Monday, June 30, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry
  • MNEXSPIKE
    Friday, June 27, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who have been previously vaccinated with any...
  • FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
    Friday, June 27, 2025 from Food and Drug Administration--Press Releases
    FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell Immunotherapies
  • Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
    Friday, June 27, 2025 from Food and Drug Administration--Recalls
    Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.
  • Devices Guidances
    Friday, June 27, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    This page lists Medical Device Guidance documents.
  • ABECMA (idecabtagene vicleucel)
    Friday, June 27, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    ABECMA is the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal...
  • FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
    Thursday, June 26, 2025 from What's New: Vaccines, Blood & Biologics RSS Feed
    The REMS for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies have been eliminated because the FDA has determined that a REMS is no longer necessary.
  • Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
    Thursday, June 26, 2025 from Food and Drug Administration--Recalls
    Shang Hao Jia, Inc. of South El Monte, CA is recalling 50 case of Danshi brand Spicy Shredded Tofu, because it may contains undeclared sesame.
  • Mellace Family Brands California, Inc. Issues An Allergy Alert On Undeclared Milk Allergen In Wegmans Semi-Sweet Chocolate Nonpareils
    Wednesday, June 25, 2025 from Food and Drug Administration--Recalls
    Mellace Family Brands California, Inc. of Warren, OH is recalling Wegmans Semi – Sweet Chocolate Nonpareils, because they contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious...
  • Kilwins Quality Confections, LLC. Issues Allergy Alert on Undeclared Pecans in Mocha Truffles
    Wednesday, June 25, 2025 from Food and Drug Administration--Recalls
    Kilwins Quality Confections, LLC., of Petoskey, Michigan, is voluntarily recalling Mocha Truffles because they may contain undeclared pecans.
  • Meds for Vets. Sandy, UT. 483 issued 02/21/2025
    Monday, June 23, 2025 from ORA Reading Room RSS Feed
    Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 02/21/2025 Short Title (70 char) Meds for Vets. Sandy, UT. 483 issued 02/21/2025 FEI Number 3003829708 Firm Name Meds for Vets Record Type 483 State...
  • LEESAR, Inc. Fort Myers, FL. 483 issued 05/09/2025
    Monday, June 23, 2025 from ORA Reading Room RSS Feed
    Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 05/09/2025 Short Title (70 char) LEESAR, Inc. Fort Myers, FL. 483 issued 05/09/2025 FEI Number 3010166880 Firm Name LEESAR, Inc. Record Type 483...
  • STAQ Pharma of Ohio, LLC. Columbus, OH. 483 issued 05/16/2025
    Monday, June 23, 2025 from ORA Reading Room RSS Feed
    Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 05/16/2025 Short Title (70 char) STAQ Pharma of Ohio, LLC. Columbus, OH. 483 issued 05/16/2025 FEI Number 3025336457 Firm Name STAQ Pharma of Ohio,...
  • Sabores Bakery, Dba Sabores A Tu Mesa, Issues Allergy Alert on Undeclared Milk in Mousse Desserts
    Friday, June 20, 2025 from Food and Drug Administration--Recalls
    Sabores Fit Bakery of Kissimmee, FL is recalling MOUSSE DESSERTS, because they may contain undeclared Milk, Eggs, Soy Ingredients (Soybean oil, Soy Lecithin), Wheat, Tree Nuts ( Almonds, Hazelnuts ). People who have an allergy or severe...
  • Face Rock Creamery Voluntarily Recalls Vampire Slayer Garlic Cheddar Curds Because of Possible Health Risk
    Friday, June 20, 2025 from Food and Drug Administration--Recalls
    Face Rock Creamery of Bandon, Oregon is voluntarily recalling two specific lots of its Vampire Slayer Garlic Cheddar Curds, 6oz. cups, Use By date 08292025, because it has the potential to be contaminated with Listeria monocytogenes, an...
  • International Foodsource, LLC. Issues Allergy Alert in Nonpareil, Semi-Sweet Chocolate (Christmas Seeds) Sold as Dark Chocolate Nonpareils
    Friday, June 20, 2025 from Food and Drug Administration--Recalls
    International Foodsource, LLC of Randolph NJ is recalling 10 oz packages of Southeastern Grocers Dark Chocolate Nonpareils, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of...
  • Ideal Specialty Apothecary Inc., dba Ideal Pharmacy, Union, NJ. 483 Issued 08/31/2017
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Ideal Specialty Apothecary Inc., dba Ideal Pharmacy, Union, NJ. 483 Issued 08/31/2017 Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page Record Date 08/31/2017 FEI Number 3013505558 Firm...
  • Advanced Nutriceuticals LLC. Indianapolis, IN. 483 issued 11/22/2024
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 11/22/2024 Short Title (70 char) Advanced Nutriceuticals LLC. Indianapolis, IN. 483 issued 11/22/2024 FEI Number 3010039017 Firm Name Advanced...
  • Essential Pharmacy Compounding, Omaha, NE., 483 Issued 05/22/2015
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Task Description Request Please post to the 2015 Pharmacy Inspections and Related Records page. Record Date 05/22/2015 FEI Number 3003718003 Firm Name Essential Pharmacy Compounding Record Type 483 State NE Establishment Type Producer of...
  • New England Home Therapies Inc. Southborough, MA. 483 Issued 01/27/2016
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Record Date 01/27/2016 FEI Number 1000120535 Firm Name New England Home Therapies Inc. Record Type 483 State MA Establishment Type Producer of Sterile Drug Products
  • Akorn Pharmaceuticals Inc. Decatur, IL. 483 Issued 06/10/2016
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Akorn Pharmaceuticals Inc. Decatur, IL. 483 Issued 06/10/2016
  • Lipari Foods Issues Allergy Alert on Undeclared Milk in "Dark Chocolate Nonpareils"
    Friday, June 20, 2025 from Food and Drug Administration--Recalls
    Lipari Foods of Warren, MI, is recalling its 14-ounce packages of JLM Branded “Dark Chocolate Nonpareils" food treats because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening...
  • Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceuticals, Los Angeles, CA. Amended 483 Issued 03/23/2017
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceuticals, Los Angeles, CA. Amended 483 Issued 03/23/2017 Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page Record Date 03/23/2017 FEI Number...
  • Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceutical, Los Angeles, CA. 483 Issued 03/23/2017
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceutical, Los Angeles, CA. 483 Issued 03/23/2017 Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page Record Date 03/23/2017 FEI Number...
  • Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceuticals, Los Angeles, CA. 483, Second Amended 483 Issued 03/23/2017
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page Record Date 03/23/2017 FEI Number 3013341563 Firm Name Fusion IV Pharmaceuticals Inc. dba Axia Pharmaceutical Record Type 483 State CA...
  • Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. Los Angeles, CA. Amended 483 issued 12/20/2019
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    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...
  • Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI, 483 Issued 2/28/2013
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI, 483 Issued 2/28/2013
  • Lincare, Inc. dba United Medical Home Infusion, Little Rock, AR. 483 Issued 08/22/2017
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Lincare, Inc. dba United Medical Home Infusion, Little Rock, AR. 483 Issued 08/22/2017 Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page Record Date 08/22/2017 FEI Number 3011564121 Firm...
  • Lincare, Inc. dba United Medical Home Infusion, Little Rock, AR. State Referral Letter Issued 03/05/2018
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Lincare, Inc. dba United Medical Home Infusion, Little Rock, AR. State Referral Letter Issued 03/05/2018 Task Description Request Please post to the 2018 Pharmacy Inspections and Related Records Web page Record Date 03/05/2018 FEI Number...
  • Biocon Sdn. - 8/30/2022
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Biocon Sdn. - 8/30/2022. Country: Malaysia. Record Type: 483
  • Biocon Sdn Bhd - 9/27/2024
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Biocon Sdn Bhd - 9/27/2024. Country: Malaysia. Record Type: 483
  • Laboratorios Farmeceuticos Rovi, SA - 5/19/2023
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Laboratorios Farmeceuticos Rovi, SA - 5/19/2023. Country: Spain. Record Type: 483
  • Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA 483 Issued 3/11/2015
    Friday, June 20, 2025 from ORA Reading Room RSS Feed
    Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA 483 Issued 3/11/2015
  • FDA Halts New Clinical Trials That Export Americans’ Cells to Foreign Labs in Hostile Countries for Genetic Engineering
    Wednesday, June 18, 2025 from Food and Drug Administration--Press Releases
    FDA Halts New Clinical Trials That Export Americans’ Cells to Foreign Labs in Hostile Countries for Genetic Engineering
  • Weaver Nut Company Inc., Issues Allergy Alert on Undeclared Milk in Chocolate Nonpareils
    Tuesday, June 17, 2025 from Food and Drug Administration--Recalls
    Weaver 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 of serious or...
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