REGULATORY UPDATE: CBER Presents Research Programs During Recent BPAC Meeting

The Food and Drug Administration’s Blood Products Advisory Committee (BPAC) met recently in open session to hear an overview of two of the agency’s regulatory science research laboratories: the Laboratory of Emerging Pathogens (LEP) and the Laboratory of Molecular Virology (LMV).

Both laboratories are located in the Division of Emerging and Transfusion Transmitted Diseases (DETTD), which is part of the Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER).

During the meeting, FDA’s leadership, principal investigators and other experts presented on these research programs, which provide an essential part of the Center’s work to support public health. Monica Young, PhD, opened the program with an overview of CBER research programs, followed by an overview of OBRR’s research programs, presented by Chintamani Atreya, PhD.

Next, Hira Nakhasi, PhD, presented an overview of the DETTD research programs. This was followed by an overview of the LEP research programs given by Sanjai Kumar, PhD, and an overview of the LMV research programs presented by Indira Hewlett.

Following the open session presentations, the meeting was closed to the public for Committee discussions. Materials from the meeting will be posted on AABB’s BPAC web page.

Earlier this month, AABB, America’s Blood Centers and the American Red Cross issued a joint statement voicing its continued support for FDA’s regulatory science research laboratories and scientists. “It is vital to attract and retain career research scientists with critical scientific expertise within the FDA and to adequately fund the agency’s research to facilitate the assessment of interventions that ensure the continued safety of the blood supply and support effective, efficient regulatory review of life-saving blood and biological products,” the organizations wrote.

Members with questions may contact regulatory@aabb.org.