Blood Products Advisory Committee
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Blood Products Advisory Committee (BPAC) is part of the U.S. Food and Drug Administration (FDA) and provides advice on matters related to blood, blood products, and biotechnological products intended for use in the diagnosis, prevention, or treatment of human diseases. The committee is based in Silver Spring, Maryland, and is tasked with ensuring the safety and efficacy of these products.
Mission
BPAC's mission is to advise the FDA on regulatory issues concerning blood products. This includes reviewing the safety, effectiveness, and appropriate use of blood products, considering labeling, clinical and laboratory studies, and research programs to support regulatory decisions.[1]
Parent organization
BPAC is part of the Food and Drug Administration (FDA), which falls under the Department of Health and Human Services. The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
Legislation
While not established by a specific piece of legislation, BPAC operates under the authority of the FDA, which is empowered by various acts like the Federal Food, Drug, and Cosmetic Act. Its activities are influenced by broader regulatory frameworks concerning biological products.
Partners
- Blood banks and transfusion services for data and practical insights
- Academic and research institutions for collaborative research
- Pharmaceutical and biotechnology companies for product development reviews
Number of employees
The committee itself does not have permanent employees but consists of appointed members, including experts in hematology, infectious diseases, epidemiology, and blood banking.
Organization structure
BPAC's structure includes:
Leader
The proceedings of the committee are managed by the Designated Federal Officer (DFO).
Divisions
- No formal divisions; operates as a single committee with members selected for their expertise.
List of programs
- Meetings to discuss specific blood product applications or broader policy issues
- Review of new blood products, testing methods, and donor screening processes
- Public forums on blood safety and advancements in transfusion medicine
Last total enacted budget
Specific budget information for BPAC is not publicly disclosed, as it is part of the FDA's broader budgetary allocations for advisory committees.
Staff
Staffing for meetings includes the DFO and support from FDA staff; the committee members serve as external experts.
Funding
Funding for BPAC activities is part of the FDA's overall budget for advisory committee operations.
Services provided
BPAC provides recommendations on the approval, labeling, and post-marketing surveillance of blood products. It focuses on ensuring these products are safe and effective, considering the risks of transfusion-transmitted diseases and the quality of blood components.[2]
Headquarters address
10903 New Hampshire Ave, Silver Spring, MD 20993
History
BPAC was established to provide scientific and technical advice on blood products, with its charter regularly renewed, typically every two years. It has played a significant role in shaping FDA policies on blood safety, especially during times of emerging infectious diseases or technological advancements in blood product manufacturing.
External links
References
- ↑ Food and Drug Administration (2025). "Blood Products Advisory Committee". FDA.
- ↑ Food and Drug Administration (2025). "Blood Products Advisory Committee Meetings". FDA.