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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
Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
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
Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Guidance for Industry  Food and Drug Administration (FDA) Final
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Increase in Public/Private Partnership (PPP) Refugee Cash Assistance (RCA) Monthly Payment Ceilings  Administration for Children and Families (ACF) Final
Use of FVPSA Funds for match to HUD DV Bonus Grant Programs FAQ  Administration for Children and Families (ACF) Final
Further Extension of Grace Period Related to the “Four Walls” Requirement under 42 C.F.R. § 440.90 for Indian Health Service and Tribal Facilities to Nine Months after the COVID-19 PHE Ends  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 4742 documents.