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Posted 06 January 2017 | By Michael Mezher
The US Food and Drug Administration's (FDA) Center for Biologics Research and Evaluation (CBER) has once again met or exceeded its performance goals for reviewing and acting on product applications and supplements, according to a report released Thursday from CBER Director Peter Marks.
The report is Marks' first since he rose to head CBER last January, replacing former CBER Director Karen Midthun after her 22-year stint at the agency.
As in previous years, CBER met or exceeded the performance goals for product reviews established by the various User Fee Acts:
Compared with 2015, CBER saw fewer Biologic License Applications (BLAs) with eight BLAs falling within the FY2016 review timeframe as opposed to 13 in FY2015.
Aside from hitting its performance targets for reviews, CBER published a total of 12 guidance documents in FY2016, four of which were published in cooperation with the Center for Drug Evaluation and Research (CDER) or the Center for Devices and Radiological Health (CDRH).
The guidances include four final guidances and six draft guidances, as well as two guidances for immediate implementation intended to reduce the risk of Zika virus transmission.
FY2016 Report from the Director
Tags: CBER, PDUFA, MDUFA, BLA
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