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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
Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability  Food and Drug Administration (FDA) Final
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process  Food and Drug Administration (FDA) Final
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products  Food and Drug Administration (FDA) Final
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry  Food and Drug Administration (FDA) Final
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Final
Q8(R2) Pharmaceutical Development  Food and Drug Administration (FDA) Final
Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider)  Food and Drug Administration (FDA) Final
Q8, Q9, and Q10 Questions and Answers  Food and Drug Administration (FDA) Final
Q9(R1) Quality Risk Management  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4741 documents.