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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
Enforcement Policy for Certain Marketed Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5569 documents.