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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 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
Labeling OTC Human Drug Products Using a Column Format  Food and Drug Administration (FDA) Final
Laser Energy Source (Laser Notice 2)  Food and Drug Administration (FDA) Final
Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22)  Food and Drug Administration (FDA) Final
Lasers Manufactured and Used In-House (Laser Notice 14)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.