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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
Listing of Ingredients in Tobacco Products: Guidance for Industry  Food and Drug Administration (FDA) Final
M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES: Guidance for Industry  Food and Drug Administration (FDA) Final
Male Breast Cancer: Developing Drugs for Treatment: Guidance for Industry  Food and Drug Administration (FDA) Final
Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms: Guidance for Industry  Food and Drug Administration (FDA) Final
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency: Guidance for Industry  Food and Drug Administration (FDA) Final
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry  Food and Drug Administration (FDA) Final
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for Industry  Food and Drug Administration (FDA) Final
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.