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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
Q4B Annex 9: Tablet Friability General Chapter  Food and Drug Administration (FDA) Final
Q4B Annex I: Residue on Ignition/Sulphated Ash General Chapter  Food and Drug Administration (FDA) Final
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Annex 13: Bulk Density and Tapped Density of Powders General Chapter  Food and Drug Administration (FDA) Final
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 11: Capillary Electrophoresis General Chapter  Food and Drug Administration (FDA) Final
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 12: Analytical Sieving General Chapter  Food and Drug Administration (FDA) Final
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 14: Bacterial Endotoxins Test General Chapter  Food and Drug Administration (FDA) Final
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions  Food and Drug Administration (FDA) Final
Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin  Food and Drug Administration (FDA) Final
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products  Food and Drug Administration (FDA) Final
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.