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FDA Guidance for Indutry M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

This guidance primarily addresses the organization of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived and biological products).

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