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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
CVM GFI #53 Evaluation of the Utility of Food Additives in Diet Fed to Aquatic Animals  Food and Drug Administration (FDA) Final
CVM GFI #55 Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Protocol Development  Food and Drug Administration (FDA) Final
Data Standards Catalog  Food and Drug Administration (FDA) Final
Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products  Food and Drug Administration (FDA) Final
Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Development of New Stereoisomeric Drugs  Food and Drug Administration (FDA) Final
Device Labeling Guidance #G91-1 (Blue Book Memo)  Food and Drug Administration (FDA) Final
Drug Master Files: Guidelines  Food and Drug Administration (FDA) Final
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) Guidance for Industry  Food and Drug Administration (FDA) Final
FDA's Strategy on Antimicrobial Resistance - Questions and Answers  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.