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FDA Guidance for Industry: M4E(R2): The CTD – Efficacy

Origin/Publisher:

FDA

Content:
At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Steering Committee to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Health Canada and Switzerland) for internal and external consultation, according to national or regional procedures.

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