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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
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q1B Photostability Testing of New Drug Substances and Products  Food and Drug Administration (FDA) Proposed
Q3C: Appendix 6  Food and Drug Administration (FDA) Proposed
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
Q3C: Appendix 4  Food and Drug Administration (FDA) Proposed
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products  Food and Drug Administration (FDA) Proposed
Endogenous Cushing’s Syndrome: Developing Drugs for Treatment  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
Early Alzheimer’s Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5569 documents.