JSM 2012 Online Program

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*325 !**	Tue, 7/31/2012, 10:30 AM - 12:20 PM	HQ-Sapphire L
Regulatory Review Issues for Medical Devices and Diagnostics — Topic Contributed Papers
Biopharmaceutical Section
Organizer(s): Jianxiong Chu, FDA/CDRH
Chair(s): Jianxiong Chu, FDA/CDRH
10:35 AM	Validation of Prognostic Biomarker in a Regulatory Submission: A Science-Based Approach — Rong Tang, FDA ; Gene Pennello, FDA
10:55 AM	Quality Statistical Review Checklist of Investigational Device Exemption (IDE) Submissions for Diagnostic Medical Devices — R. Lakshmi Vishnuvajjala, FDA/CDRH
11:15 AM	Regulatory Issues Associated with Prognostic Biomarker Evaluation — Kyunghee Song, FDA/CDRH
11:35 AM	Subgroup Gender Analysis in Medical Device Trials — Songtao Jiang, Boston Scientific Corporation ; Peter Lam, Boston Scientific Corporation ; Hong Wang, Boston Scientific Corporation ; Milan Seth, Boston Scientific Corporation
11:55 AM	Quality Statistical Review Checklist of Investigational Device Exemption (IDE) Submissions for Therapeutic and Aesthetic Medical Devices — Greg Campbell, FDA ; Lilly Yue, FDA
12:15 PM	Floor Discussion

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