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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
Q3C: Appendix 4  Food and Drug Administration (FDA) Proposed
Q3C: Appendix 6  Food and Drug Administration (FDA) Proposed
Qualification of Biomarker — Galactomannan in studies of treatments of invasive  Food and Drug Administration (FDA) Proposed
Quality Considerations for Topical Ophthalmic Drug Products  Food and Drug Administration (FDA) Proposed
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products  Food and Drug Administration (FDA) Proposed
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products  Food and Drug Administration (FDA) Proposed
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method  Food and Drug Administration (FDA) Proposed
Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects  Food and Drug Administration (FDA) Proposed
Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act  Food and Drug Administration (FDA) Proposed
Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.