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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
Clinical Evaluation of Antiepileptic Drugs (adults and children)  Food and Drug Administration (FDA) Final
Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling  Food and Drug Administration (FDA) Final
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies  Food and Drug Administration (FDA) Final
Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product  Food and Drug Administration (FDA) Final
Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format  Food and Drug Administration (FDA) Final
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics  Food and Drug Administration (FDA) Final
Clinical Trial Imaging Endpoint Process Standards Guidance for Industry  Food and Drug Administration (FDA) Final
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.