IMD-A USP<1223> Validation Tests
IMD-A Specificity Testing
Rapid Methods Validation Package Guidance for EU Countries
Recommended IMD-A Implementation Steps for EU Customers
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
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