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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
Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events  Food and Drug Administration (FDA) Final
Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)  Food and Drug Administration (FDA) Final
Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro  Food and Drug Administration (FDA) Final
Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation  Food and Drug Administration (FDA) Final
Migraine: Developing Drugs for Acute Treatment  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4741 documents.