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CBER and MDUFMA Quantitative Goals

CBER and MDUFMA Quantitative Goals. Mary Elizabeth Jacobs, Ph.D. Acting Deputy Director Office of Blood Research and Review, CBER MDUFMA Stakeholders Meeting November 18, 2004. Modular PMAs. Module submission timing worked out with review division Most are HIV diagnostics

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CBER and MDUFMA Quantitative Goals

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  1. CBER and MDUFMA Quantitative Goals Mary Elizabeth Jacobs, Ph.D. Acting Deputy Director Office of Blood Research and Review, CBER MDUFMA Stakeholders Meeting November 18, 2004

  2. Modular PMAs • Module submission timing worked out with review division • Most are HIV diagnostics • Most CBER PMAs since 2000 are modular

  3. CBER Modular PMA Data FY 00 - FY 04Number of Modules Received

  4. CBER Modular PMA Data FY 00 - FY 04Avg. Review Time Per Cycle

  5. CBER Modular PMA Data FY 00 - FY 04Avg. # of Review Cycles

  6. CBER Modular Data FY 00 – FY 03

  7. Goals • CBER will work with CDRH on approach to modular goals • CBER met non-modular FY 05 cycle and decision goals in FY 03 and FY 04

  8. GMP Process • Same basic process as CDRH • Manufacturing review: Product Division • QSR: OCBQ and Product Division • Evaluating CDRH timing • Will work with district PMA coordinators • CBER contact

  9. BIMO Process • BIMO member of CBER review team • Comparing timing to CBER mid cycle • CBER contact

  10. Thanks • For your attention and feedback

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