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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
Labeling for Electronic Anti-Theft Systems: Guidance for Industry  Food and Drug Administration (FDA) Final
Labeling of Red Blood Cell Units with Historical Antigen Typing Results: Guidance for Industry  Food and Drug Administration (FDA) Final
Labeling OTC Human Drug Products; Small Entity Compliance Guide: Guidance for Industry  Food and Drug Administration (FDA) Final
Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions: Guidance for Industry  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4735 documents.