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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
E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Approaches to Assessment of Overall Survival in Oncology Clinical Trials: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Streamlining the Medicaid, Children’s Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421-P)  Centers for Medicare & Medicaid Services (CMS) Proposed
Basic Health Program: Proposed Federal Funding Methodology for Program Year 2023 and Proposed Changes to Basic Health Program Regulations  Centers for Medicare & Medicaid Services (CMS) Proposed
Development of Non-Opioid Analgesics for Chronic Pain: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Erosive Esophagitis: Developing Drugs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Disseminated Coccidioidomycosis: Developing Drugs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.