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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
Dry Eye: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers  Food and Drug Administration (FDA) Proposed
E11A Pediatric Extrapolation  Food and Drug Administration (FDA) Final
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs  Food and Drug Administration (FDA) Proposed
E19 OPTIMISATION OF SAFETY DATA COLLECTION  Food and Drug Administration (FDA) Proposed
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports  Food and Drug Administration (FDA) Proposed
E6(R3) Good Clinical Practice (GCP)  Food and Drug Administration (FDA) Final
Early Alzheimer’s Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment  Food and Drug Administration (FDA) Final
Endogenous Cushing’s Syndrome: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.