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Labcompliance News, January 2000

January 13, 2000

FDA Guidance on Method Validation

The US FDA is developing a draft guidance on method validation through its Analytical Methods Technical Committee. The guidance provides recommendations to applicants (NDA, ANDA, BLA, PLA) for submitting analytical procedures, validation data and standards and samples. The draft guidance is entitled "Analytical Procedures and Methods Validation" and when finalized will replace the FDA’s guidance on "Submitting Samples and Analytical Data for Methods Validation" (February 1987)". Pat Faustino from the FDA gave a presentation on preliminary results and on the current status at the conference of the Canadian Calibration and Validation Group. Download the presentation from LabCompliance User Club.