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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
REMS Assessment: Planning and Reporting  Food and Drug Administration (FDA) Proposed
REMS Logic Model: A Framework to Link Program Design With Assessment  Food and Drug Administration (FDA) Proposed
Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act  Food and Drug Administration (FDA) Proposed
Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Risk Management Plans to Mitigate the Potential for Drug Shortages  Food and Drug Administration (FDA) Proposed
Sample formats for Form FDA 356h_2011  Food and Drug Administration (FDA) Proposed
Sameness Evaluations in an ANDA — Active Ingredients  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
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3): Draft New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3).”  Food and Drug Administration (FDA) Proposed
Rheumatoid Arthritis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.