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FDA Compliance Enforcement Actions: What you need to know for clinical device trials

FDA Compliance Enforcement Actions: What you need to know for clinical device trials. The 3 rd Annual FDA Regulatory and Compliance Symposium Track 3- Pharma Product Development and Clinical Trials August 23, 2007 Cambridge, MA. The 3 rd Annual FDA Regulatory and Compliance Symposium.

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Figure 4. B. C. A. 100. 100. 300. k=3. k=3. 80. 80. 200. 60. 60. % of max. Total Coverage (of ommited data). % of max. Total Coverage (of all data excluding AAT1a ). 40. 40. 100. 20. 20. 0. 0. 0. 60. 70. 80. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. MPIb. SYA1. ADP1.

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% of max. Total Coverage (of all data excluding adk )

Figure 3. B. C. A. 80. 80. 300. k=5. k=5. 60. 200. 70. % of max. Total Coverage (of ommited data). % of max. Total Coverage (of all data excluding adk ). 40. 60. 100. 20. 0. 0. 50. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 0.68. 0.70. 0.72. 0.74. psts. purk. atpa. adk.

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FDA Compliance Enforcement Actions: What you need to know for clinical device trials

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% of max. Total Coverage (of all data excluding adk )