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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 #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines  Food and Drug Administration (FDA) Proposed
CVM GFI #239 Human Food By-Products For Use As Animal Food  Food and Drug Administration (FDA) Proposed
Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics  Food and Drug Administration (FDA) Proposed
CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus  Food and Drug Administration (FDA) Proposed
Considerations for Rescinding Breakthrough Therapy Designation  Food and Drug Administration (FDA) Proposed
CPG Sec 550.050 (Draft) Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A Toxin  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
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
Clinical Lactation Studies: Considerations for Study Design  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.