Tarius SAC Tracker®
Background Analysis: US FDA Advisory Committee to Hear Updates on CBER Research Programs – JUN 22, 2018 (BPAC)
The US FDA has scheduled a Blood Products Advisory Committee (BPAC) meeting for Friday, June 22, 2018. The Committee will hear presentations on research programs of two offices under the Center for Biologics Evaluation and Research (CBER): the Office of Blood Research and Review (OBRR); and the Office of Tissues and Advanced Therapies (OTAT).
A portion of the meeting will be closed to the public in order to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). At this time, the Committee will give input regarding the progress of this research, which will, along with other information, be used to make personnel and staffing decisions.
In the morning open session, under Topic I, the Committee will hear presentations on the OBRR research programs in the Laboratory of Emerging Pathogens (LEP), the Laboratory of Bacterial and Transmissible Spongiform Encephalopathy (TSE) Agents (LBTSE), and from the Laboratory of Molecular Virology (LMV) in the Division of Emerging and Transfusion-Transmitted Diseases (DETTD).
In the afternoon open session, under Topic II, the Committee will hear presentations on the OTAT research program in the Hemostasis Branch (HB), in the Division of Plasma Protein Therapeutics (DPPT).
Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA and the Sponsor’s (if applicable) briefing materials.
Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.
METADATA: Sponsor: none Drug Name: none Drug Class: none Indication: none
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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.