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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
CVM GFI #99 (VICH GL17) Testing of New Biotechnological/Biological Products  Food and Drug Administration (FDA) Final
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease  Food and Drug Administration (FDA) Final
Dear Health Care Provider Letters: Improving Communication of Important Safety Information  Food and Drug Administration (FDA) Final
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry  Food and Drug Administration (FDA) Final
Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)  Food and Drug Administration (FDA) Final
Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations  Food and Drug Administration (FDA) Final
Determining Whether to Submit an ANDA or a 505(b)(2) Application  Food and Drug Administration (FDA) Final
Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments  Food and Drug Administration (FDA) Final
Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications  Food and Drug Administration (FDA) Final
Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.