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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
Monoclonal Antibodies Used as Reagents in Drug Manufacturing  Food and Drug Administration (FDA) Final
Mouse Embryo Assay for Assisted Reproduction Technology Devices  Food and Drug Administration (FDA) Final
Naming of Drug Products Containing Salt Drug Substances  Food and Drug Administration (FDA) Final
National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs  Food and Drug Administration (FDA) Final
NDAs: Impurities in Drug Substances  Food and Drug Administration (FDA) Final
Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers  Food and Drug Administration (FDA) Final
Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention  Food and Drug Administration (FDA) Final
NEPA Final Guidance  Food and Drug Administration (FDA) Final
New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products  Food and Drug Administration (FDA) Final
New/Revised/Withdrawn Guidances 2014  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.