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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
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rheumatoid Arthritis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
Risk Management Plans to Mitigate the Potential for Drug Shortages  Food and Drug Administration (FDA) Proposed
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products  Food and Drug Administration (FDA) Proposed
Sameness Evaluations in an ANDA — Active Ingredients  Food and Drug Administration (FDA) Proposed
Sample formats for Form FDA 356h_2011  Food and Drug Administration (FDA) Proposed
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations  Food and Drug Administration (FDA) Proposed
SPL Standard for Content of Labeling Technical Qs & As  Food and Drug Administration (FDA) Proposed
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.