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Regulatory

BioVigilant Support Documentation

Performance Testing

IMD-A USP<1223> Validation Tests
IMD-A Specificity Testing

Regulatory Guidance

Rapid Methods Validation Package Guidance for EU Countries
Recommended IMD-A Implementation Steps for EU Customers

US/FDA

Minutes of Azbil BioVigilant FDA Teleconference, November 2011
Minutes of Regulatory Roundtable, October 2011 US IMD Consortium Meeting
Bryan Riley’s Recommendations for Communication IMD-A Validation Activities
with FDA 

Sample FDA Research Exemption Letter for IMD-A Use

Regulatory Links

Guidance for Industry:  PAT — A Framework for Innovative Pharmaceutical
Development, Manufacturing, and Quality Assurance

US FDA

September 2004

Rapid Microbiology Methods:  A Regulatory Viewpoint
Bryan Riley, US FDA CDER
PDA Meeting, Milan, Italy
June 2003