FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Title:
FDA Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use
in the ICH Regions
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073405.pdf
Content:
This document describes a process for the evaluation and recommendation by the Q4B Expert
Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by
regulatory authorities for use as interchangeable in the ICH regions.