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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
Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Action Levels for Lead in Juice  Food and Drug Administration (FDA) Proposed
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format  Food and Drug Administration (FDA) Proposed
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices  Food and Drug Administration (FDA) Proposed
Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products  Food and Drug Administration (FDA) Proposed
Development of Local Anesthetic Drug Products With Prolonged Duration of Effect  Food and Drug Administration (FDA) Proposed
Development of a Shared System REMS Guidance for Industry  Food and Drug Administration (FDA) Proposed
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data  Food and Drug Administration (FDA) Proposed
Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 11397 documents.