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CBER and MDUFMA Quantitative Goals Presentation Summary by Mary Elizabeth Jacobs, Ph.D.

In the November 18, 2004, MDUFMA Stakeholders Meeting, Mary Elizabeth Jacobs, Ph.D., presented the quantitative goals for CBER and MDUFMA. Key points included the successful implementation of Modular PMAs, particularly in HIV diagnostics, and the collaborative efforts between CBER and CDRH on modular goals. The report highlighted the review cycles, submission timings, and average review times for PMAs from FY 2000 to FY 2004. Jacobs emphasized CBER’s achievements in meeting non-modular cycle and decision goals in fiscal years 2003 and 2004, while also detailing the consistency of GMP processes.

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CBER and MDUFMA Quantitative Goals Presentation Summary by Mary Elizabeth Jacobs, Ph.D.

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Presentation Transcript

  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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