HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title	OpDiv/StaffDiv	Guidance Status	Issue Date
M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers	Food and Drug Administration (FDA)	Final	3/13/2013
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry	Food and Drug Administration (FDA)	Final	10/3/2017
M4: The CTD -- General Questions and Answers	Food and Drug Administration (FDA)	Final	12/22/2004
M4: The CTD -- Efficacy Questions and Answers	Food and Drug Administration (FDA)	Final	12/1/2004
M4: The CTD -- Quality	Food and Drug Administration (FDA)	Final	8/1/2001
M4: The CTD -- Quality Questions and Answers /Location Issues	Food and Drug Administration (FDA)	Final	6/9/2004
M4: The CTD -- Safety Questions and Answers	Food and Drug Administration (FDA)	Final	2/4/2003
M4E(R2): The CTD – Efficacy	Food and Drug Administration (FDA)	Final	7/24/2017
M4S: The CTD -- Safety	Food and Drug Administration (FDA)	Final	8/1/2001
M4S: The CTD -- Safety Appendices	Food and Drug Administration (FDA)	Final	8/1/2001

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