FDA | Biologics Effectiveness and Safety (BEST)


To identify adverse events (AEs) or health outcomes of interest (HOIs) in health care databases including administrative claims, electronic health records [EHR], and linked claims-EHRs, rule-based algorithms are developed utilizing reimbursement or health care management coding systems as well as clinical and auxiliary data elements. These algorithms may also apply health care settings, demographic and other specific population characteristics, and time criteria. Based on prevalence and clinical characteristics, some of these algorithms may be feasible to be validated by reviewing patients’ medical records. The health outcomes may be employed as outcomes, identification of study populations, or covariates in observational studies depending on the study objectives. The portability of these algorithms across populations and databases depends on the similarities of the populations and databases characteristics.

Tissues & Advanced Therapeutics

Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. The Center for Biologics Evaluation and Research (CBER) regulates HCT/Ps under 21 CFR Parts 1270 and 1271. Examples of such tissues are bone, skin, corneas, ligaments, tendons, dura mater, heart valves, hematopoietic stem/progenitor cells derived from peripheral and cord blood, oocytes and semen.

CBER regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. Cellular therapy products include cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications, including hematopoetic stem cells and adult and embryonic stem cells. Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.

Blood & Blood Products

The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply.

Publications & Presentations

Transparency is a fundamental principle of the operations of the CBER Surveillance Program including the BEST Initiative, Sentinel System, CMS collaboration, and others. Knowledge acquired from the surveillance activities is placed in the public domain. To accomplish this aim, information concerning surveillance activities will be made available on the BEST website and other locations when appropriate.

Vaccines & Allergenics

The Center for Biologics Evaluation and Research (CBER) regulates vaccine products. Many of these are childhood vaccines that have contributed to a significant reduction of vaccine-preventable diseases. CBER regulates allergenic products. There are currently three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests.