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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
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
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation  Food and Drug Administration (FDA) Proposed
Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome Instrument for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use  Food and Drug Administration (FDA) Proposed
Evaluation of Therapeutic Equivalence  Food and Drug Administration (FDA) Proposed
Exculpatory Language in Informed Consent  Food and Drug Administration (FDA) Proposed
Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers  Food and Drug Administration (FDA) Proposed
Fabry Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.