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On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States.
On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States. This guidance enforces the ICH Q3C Guideline for Residual Solvents.
On August 4, 2008, the FDA also issued five ICH draft guidelines for review and consultation under Step 3 of the ICH process.
The five ICH guidelines that were released are: