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FDA final guidance on bioresearch review and inspections of medical devices.(Regulatory Update)

Publication: Research Practitioner
Publication Date: 01-MAR-08
Format: Online
Delivery: Immediate Online Access

Article Excerpt
In the January 8, 2008, Federal Register, FDA announced the availability of a guidance document titled The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program. This guidance document provides applicants of premarket approval (PMA) applications the...

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...with information about bioresearch monitoring (BIMO) review process. This includes a BIMO evaluation of...

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