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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
Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern  Food and Drug Administration (FDA) Proposed
CVM GFI #142 (VICH GL29) Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)  Food and Drug Administration (FDA) Proposed
CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)  Food and Drug Administration (FDA) Proposed
Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials  Food and Drug Administration (FDA) Proposed
CVM GFI #116 (VICH GL23 (R2)) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2)  Food and Drug Administration (FDA) Proposed
CPG Sec 575.100 Draft Revision - Pesticide Chemical Residues in Food - Enforcement Criteria  Food and Drug Administration (FDA) Proposed
CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines  Food and Drug Administration (FDA) Proposed
Crohn’s Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5488 documents.