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RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
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Posted 17 December 2015 | By Michael Mezher
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) says it met or exceeded its performance goals for FY2015, according to a new report.
Notably, the FY2015 Report from the Director will be the last under CBER Director Dr. Karen Midthun's leadership. Midthun is set to retire at the end of 2015, ending her 22 year career at FDA.
As in previous years, CBER met or exceeded the performance goals for product reviews established by the various User Fee Acts:
2 regulatory science projects awarded Ebola supplemental funding
2 regulatory science projects awarded challenge grant funding
CBER also had a relatively busy year for reviews, in FY2015 the center approved 13 new biological license applications (BLAs), four of which were new vaccines.
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
The report also emphasizes CBER's role in the response to the Ebola outbreak in West Africa.
During the reporting period, CBER says it mobilized its experts on the Vaccines and Related Biological Products Advisory Committee and organized a workshop with other government agencies intended to "inform future clinical, scientific and regulatory decision-making related to vaccines against Ebola."
Additionally, CBER says it expedited the review of multiple investigational vaccines to treat Ebola, and lent its expertise to sponsors in pre-IND meetings for Ebola vaccine candidates.
On an international scale, CBER said it participated in 14 meetings with other regulatory authorities and provided expert advice at World Health Organization (WHO) consultations in its efforts to combat Ebola.
FDA
Tags: CBER, Center for Biologics Evaluation and Research
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