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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
Evaluation of Therapeutic Equivalence  Food and Drug Administration (FDA) Proposed
Proposed Rule: Medicaid Managed Care State Directed Payments and Medicaid Fee-For-Service Targeted Medicaid Practitioner Payments (CMS-2449-P)  Centers for Medicare & Medicaid Services (CMS) Proposed
Exculpatory Language in Informed Consent  Food and Drug Administration (FDA) Proposed
Fabry Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Voluntary Disclosure of Sesame as an Allergen  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products  Food and Drug Administration (FDA) Proposed
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing  Food and Drug Administration (FDA) Proposed
Establishing Impurity Specifications for Antibiotics  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3992 documents.