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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
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices  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Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Enforcement Policy for Certain Marketed Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4128 documents.