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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
Conducting Clinical Trials With Decentralized Elements  Food and Drug Administration (FDA) Final
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies  Food and Drug Administration (FDA) Final
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products  Food and Drug Administration (FDA) Final
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials  Food and Drug Administration (FDA) Final
Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry  Food and Drug Administration (FDA) Final
Container Closure System and Component Changes: Glass Vials and Stoppers  Food and Drug Administration (FDA) Final
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers  Food and Drug Administration (FDA) Final
Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers  Food and Drug Administration (FDA) Final
Contents of a Complete Submission for the Evaluation of Proprietary Names  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.