The presentation details the addition of triethylamine to the guideline on toxic solvents. In November 2016, the International Council for Harmonization (ICH) published Q3C(R6), which added ...
Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents.
The US Food and Drug Administration (FDA) on Tuesday launched a two-month public consultation on an International Council for Harmonisation (ICH) guideline establishing new permitted daily exposures ...
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