Q&A Guidance on ICH Guidelines from the FDA for Drug Production

As part of their effort to provide clearer directions for industry, the FDA recently published a new guidance document for ICH Q8, Q9, and Q10.

This document is taken from questions asked during training sessions, and may help to in the implementation of the ICH Guidelines.

A pdf version is available at the FDA website. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM313094.pdf