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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Secretariat, Chemin des Mines 9, P.O. Box 195, 1211 Geneva 20, Switzerland

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ICH HARMONISED GUIDELINE

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I ADDENDUM TO ICH E6(R1 ... - ICH Official web site

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Guideline on strategies to identify and mitigate …

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§310.547 21 CFR Ch. I (4–1–99 Edition)

60 §312.3 21 CFR Ch. I (4–1–99 Edition) prescription drug product, the inves-tigation is not intended to support a significant change in the advertising

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