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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
M12 Drug Interaction Studies  Food and Drug Administration (FDA) Final
M12 Drug Interaction Studies: Questions and Answers  Food and Drug Administration (FDA) Final
M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms  Food and Drug Administration (FDA) Final
M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals  Food and Drug Administration (FDA) Final
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
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry  Food and Drug Administration (FDA) Final
M4: The CTD -- General Questions and Answers  Food and Drug Administration (FDA) Final
M4: The CTD -- Efficacy Questions and Answers  Food and Drug Administration (FDA) Final
M4: The CTD -- Quality  Food and Drug Administration (FDA) Final
M4: The CTD -- Quality Questions and Answers /Location Issues  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.