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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
Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for Industry  Food and Drug Administration (FDA) Final
Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry  Food and Drug Administration (FDA) Final
Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems : Guidance for Industry  Food and Drug Administration (FDA) Final
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry  Food and Drug Administration (FDA) Final
Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality: Guidance for Industry  Food and Drug Administration (FDA) Final
How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1): Guidance for Industry  Food and Drug Administration (FDA) Final
How to Prepare a Pre-Request for Designation (Pre-RFD): Guidance for Industry  Food and Drug Administration (FDA) Final
How to Write a Request for Designation (RFD): Guidance for Industry  Food and Drug Administration (FDA) Final
Human Gene Therapy for Hemophilia: Guidance for Industry  Food and Drug Administration (FDA) Final
Human Gene Therapy for Neurodegenerative Diseases: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.