This page contains a listing of vaccine and related biological product guidances

This page contains a listing of cellular and gene therapy guidances.

This page contains a listing of Blood Guidances guidances.

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.