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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
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers  Food and Drug Administration (FDA) Proposed
CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact  Food and Drug Administration (FDA) Proposed
CPG Sec 540.275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coli  Food and Drug Administration (FDA) Proposed
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs  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 #282 Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals  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
Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4024 documents.