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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
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry  Food and Drug Administration (FDA) Final
Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 (Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases: Guidance for Industry  Food and Drug Administration (FDA) Final
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies: Guidance for Industry  Food and Drug Administration (FDA) Final
Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Guidance for Industry  Food and Drug Administration (FDA) Final
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.