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.
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.
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.
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.
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)....
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.
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...
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).
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...
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...
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...
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.
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...
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...
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...
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 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 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 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 Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page Record Date 08/31/2017 FEI Number 3013505558 Firm...
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...
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...
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
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 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 Task Description Request Please post to the 2017 Pharmacy Inspections and Related Records Web page Record Date 03/23/2017 FEI Number...
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...
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...
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 Task Description Request Please post to the 2018 Pharmacy Inspections and Related Records Web page Record Date 03/05/2018 FEI Number...
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...