FDA Releases Revision To Q8 Pharmaceutical Development Guidance

The FDA released this guidance revision, Guidance for Industry Q8(R1) Pharmaceutical Development, which is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that was published in May 2006. The Q8 parent guidance is revised to add an annex, which provides further clarification of the key concepts outlined in the May 2006 guidance and describes the principles of quality by design (QbD). This Q8(R1) document includes the Q8 parent guidance and the annex. This guidance is intended to provide guidance on the contents of section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use). 

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