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International Pharmaceutical Regulatory Monitor
June 2012 | Vol. 40 No. 6
U.S. May Delay Adoption of ICH’s Final API Manufacturing Guideline
The U.S. Food and Drug Administration (FDA) will likely take its time adopting an International Conference on Harmonisation (ICH) guideline that recommends drugmakers use risk assessments to identify material and process characteristics that could alter the critical quality attributes (CQAs) of active pharmaceutical ingredients (APIs).
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