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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 #49 Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula  Food and Drug Administration (FDA) Proposed
Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document  Food and Drug Administration (FDA) Proposed
CVM GFI #260 - Type VII Veterinary Master File for Research and Development and Risk Reviews  Food and Drug Administration (FDA) Proposed
Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Study of Sex Differences in the Clinical Evaluation of Medical Products  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Labeling of Plant-Based Alternatives to Animal-Derived Foods  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event  Food and Drug Administration (FDA) Proposed
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4039 documents.