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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
Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for Industry  Food and Drug Administration (FDA) Final
Qualification of Biomarker Total Kidney Volume in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease Draft Guidance for Industry  Food and Drug Administration (FDA) Final
Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Quality Assurance Guidelines for Hemodialysis Devices  Food and Drug Administration (FDA) Final
Quality Attribute Considerations for Chewable Tablets Guidance for Industry  Food and Drug Administration (FDA) Final
Quality Control Guide for Sunlamp Products (FDA 88-8234)  Food and Drug Administration (FDA) Final
Quality Control Practices for Compliance with the Federal Laser Performance Standard  Food and Drug Administration (FDA) Final
Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance Standard  Food and Drug Administration (FDA) Final
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations  Food and Drug Administration (FDA) Final
Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.