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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
Assessing User Fees Under the Biosimilar User Fee Amendments of 2022: Guidance for Industry  Food and Drug Administration (FDA) Final
Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for Industry  Food and Drug Administration (FDA) Final
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment : Guidance for Industry  Food and Drug Administration (FDA) Final
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
"Computer Crossmatch" (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's Serum or Plasma Type); : Guidance for Industry  Food and Drug Administration (FDA) Final
2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV: Guidance for…  Food and Drug Administration (FDA) Final
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for Industry  Food and Drug Administration (FDA) Final
Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.