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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
Identifying Trading Partners Under the Drug Supply Chain Security Act  Food and Drug Administration (FDA) Proposed
Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs  Food and Drug Administration (FDA) Proposed
In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs  Food and Drug Administration (FDA) Proposed
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators  Food and Drug Administration (FDA) Proposed
Labeling for Biosimilar and Interchangeable Biosimilar Products  Food and Drug Administration (FDA) Proposed
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards  Food and Drug Administration (FDA) Proposed
How to Comply with the Pediatric Research Equity Act  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Innovative Approaches for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.