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BIMO and MDUFMA

BIMO and MDUFMA. Michael E. Marcarelli, PharmD Director Division of Bioresearch Monitoring Office of Compliance CDRH. Today’s Topics. Program Goals Program Changes Program Needs. Program Goals. Greater focus on MDUFMA submissions Preliminary compliance assessment NLT Day 70/80

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BIMO and MDUFMA

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  1. BIMO and MDUFMA Michael E. Marcarelli, PharmD Director Division of Bioresearch Monitoring Office of Compliance CDRH

  2. Today’s Topics • Program Goals • Program Changes • Program Needs

  3. Program Goals • Greater focus on MDUFMA submissions • Preliminary compliance assessment NLT Day 70/80 • Final assessment NLT day 110/120

  4. PMA Timeline & BIMO Complete Assignment Issued** DMC Login EIR Recvd.*** ODE Heads-up PMA Recvd.* 483 Recvd.*** Summary to ODE -45 0 11 20 70/80 110/120 140/150 Calendar Days

  5. Program Changes • Division realignment • Inspectional focus • Outreach to Review Divisions • “Early Intervention” inspections • Continuous dialogue w/ORA

  6. Program Needs • Industry commitment • Notify review divisions of future submissions • Provide complete info in submission • Indexed or dedicated BIMO section • Names and addresses of clinical sites, IRBs, CROs etc. • All protocols, ICDs used • Line listing of data by site and subject • What else?

  7. Outcomes • BIMO process primed • HQTRS and Field • Timeframes met • Improved confidence in research • Reviewers and general public • Public Health protection and advancement

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