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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
Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment  Food and Drug Administration (FDA) Final
Label Comprehension Studies for Nonprescription Drug Products  Food and Drug Administration (FDA) Final
Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)  Food and Drug Administration (FDA) Final
Labeling for Biosimilar Products Guidance for Industry  Food and Drug Administration (FDA) Final
Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements  Food and Drug Administration (FDA) Final
Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway  Food and Drug Administration (FDA) Final
Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information  Food and Drug Administration (FDA) Final
Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers  Food and Drug Administration (FDA) Final
Labeling OTC Human Drug Products -- Questions and Answers  Food and Drug Administration (FDA) Final
Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.