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BME350 lecture 7

  1. FDA Functions
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  2. FDA General information
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  3. CBER

    CDER
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  4. Consumer Protection: Premarket, Postmarket
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  5. What does the FDA regulate:
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  6. FDA Regulatory process-flow
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  7. CDER (Drugs)-flow
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  8. CBER (Biologics)-flow
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  9. What is considered a biologic by CBER (Biologics)
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  10. CDRH Device Classification
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  11. CDRH Device Classification & Controls Required
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  12. CDRH (Devices)-Controls(2)/PMA
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  13. Class I and II CDRH Devices; 510(k) Clearance:
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  14. Premarket Notification (510(k))-Class I and II
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  15. Premarket Approval (PMA)->CDRH-Class III
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  16. Regulatory Process
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  17. Clinical Trials-IND/IDE
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  18. Institutional Review Board (IRB)-purpose
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  19. Clinical Trials-Phases
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  20. Clinical Trials (Phase I)
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  21. Clinical Trials (Phase II)
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  22. Clinical Trials (Phase III)
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  23. Clinical Trials-NDA/PLA/PMA
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Author
khaengel
ID
296837
Card Set
BME350 lecture 7
Description
BME350
Updated

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