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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
E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population  Food and Drug Administration (FDA) Final
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials  Food and Drug Administration (FDA) Proposed
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation  Food and Drug Administration (FDA) Final
Insurance Match Implementation Guide  Administration for Children and Families (ACF) Final
Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool Guidance for Industry  Food and Drug Administration (FDA) Final
Grandfathered Tribal FQHCs  Centers for Medicare & Medicaid Services (CMS) Final
Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals  Food and Drug Administration (FDA) Final
OFA "Dear Colleague" letter on TANF and Healthy Marriage/Responsible Fatherhood Social Capital Programs  Administration for Children and Families (ACF) Final
CSBG IM #154 Disaster Flexibilities and Waivers  Administration for Children and Families (ACF) Final
E18 Genomic Sampling and Management of Genomic Data Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 5570 documents.