This page contains a listing of Allergenics Guidance documents.

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.

Testing HCT/P Donors for Relevant Communicable Diseases

GRAND RAPIDS, Mich., June 13, 2025 – Meijer is announcing a recall of certain packages of Frederik’s Dark Chocolate Almonds because they may also contain dark chocolate-covered cashews, which are not declared…

Fuentes Farms of McAllen, Texas is recalling 71 Boxes of Fresh Cucumbers, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections…

Rolling BLA (Part 1 of 2) – Active immunization for the prevention of lower respiratory tract disease (LRTD) and acute respiratory disease (ARD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

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.

Turkana Food Inc. Kenilworth, NJ is recalling 352 cases of Floria Dried Apricots because the product contains UNDECLARED SULFITES on the package label.

Listing of the 2025 Biological License Application Approvals

June 12, 2025, Vita Warehouse Corp. is voluntarily recalling one lot of Welby® brand Vitamin B12 Energy Support gummy product 1000 mcg 140 gummies, Berkely Jensen® Vitamin B12 1000 mcg 250 Gummies, and…