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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
S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals : Guidance for Industry  Food and Drug Administration (FDA) Final
S6(R1) Addendum: Preclinical Safety Evaluation of Biotechnology: Guidance for Industry  Food and Drug Administration (FDA) Final
Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency: Guidance for Industry  Food and Drug Administration (FDA) Final
Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;: Guidance for Industry  Food and Drug Administration (FDA) Final
Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use: Guidance for Industry  Food and Drug Administration (FDA) Final
Size of Beads in Drug Products Labeled for Sprinkle Rev.1: Guidance for Industry  Food and Drug Administration (FDA) Final
Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans: Guidance for Industry  Food and Drug Administration (FDA) Final
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research: Guidance for Industry  Food and Drug Administration (FDA) Final
Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.