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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
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency  Food and Drug Administration (FDA) Final
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency : Guidance for Submitting Influenza Resistance Data  Food and Drug Administration (FDA) Final
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data  Food and Drug Administration (FDA) Final
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HBV Resistance Data  Food and Drug Administration (FDA) Final
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data  Food and Drug Administration (FDA) Final
Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 1040.30)  Food and Drug Administration (FDA) Final
Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53)  Food and Drug Administration (FDA) Final
Aqueous Shunts - 510(k) Submissions - Guidance for Industry and for FDA Reviewers/Staff  Food and Drug Administration (FDA) Final
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations  Food and Drug Administration (FDA) Final
Assessing User Fees Under the Generic Drug User Fee Amendments of 2022  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.