100+ Premarket review PowerPoint (PPT) Presentations, Premarket review PPTs

Premarket review - PowerPoint PPT Presentation

Testing in the Open Market

Testing in the Open Market. AAAS Colloquium on Personalized Medicine: Planning for the Future June 2, 2009. Courtney C. Harper, Ph.D. Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health/FDA courtney.harper@fda.hhs.gov.

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266 views • 17 slides

Combination Products CBER Report

Combination Products CBER Report. MDUFAMA Educational Seminar November 2002. Designation of Regulation of Combination Products. Achievements 1. Establish Office of Combination Products within 60 days 2. Prompt assignment of lead center 3. Timely and effective premarket review

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331 views • 15 slides

Condition of Approval Studies: Recent Changes in CDRH

Condition of Approval Studies: Recent Changes in CDRH. Susan Gardner, PhD Director, Office of Surveillance and Biometrics, CDRH Advisory Panel. Office of Surveillance and Biometrics: Basic Functions. Premarket review Statisticians Epidemiologists

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159 views • 9 slides

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Premarket review - PowerPoint PPT Presentation

Testing in the Open Market

Combination Products CBER Report

Condition of Approval Studies: Recent Changes in CDRH