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# CBER ‘Enhanced Operational Efficiency’ in FY 2016: Marks
- URL: https://www.fdaweb.com/cber-enhanced-operational-efficiency-in-fy-2016-marks/
- Published: 2017-01-10T12:00:00.000Z
- Updated: 2026-09-14T21:59:11.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5137677

New CBER director **Peter Marks** says that in FY 2016, the Center enhanced its operational efficiency, which facilitated getting new treatments to the public. In an [annual report](http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm535743.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), Marks says that as of 9/30/16, CBER exceeded its regulatory performance target by completing 100% of standard and priority reviews of BLAs and NDAs within specified reviewed timeframes. Similarly, he says, it exceeded the performance target for 510(k) submissions and Real Time Supplements, issuing a decision on 100% of MDUFA submissions received during FY 2016 within 90 FDA days.

“In addition,” Marks writes, “our researchers generated critically important new scientific knowledge in support of the development and regulation of safe and effective medical products…. And the Center’s rapid responses to the Ebola and Zika virus outbreaks demonstrated our ability to quickly and effectively focus regulatory and scientific knowledge and skills on the challenge of emerging international public health crises.”