Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor…  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.