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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
Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)  Food and Drug Administration (FDA) Final
Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)  Food and Drug Administration (FDA) Final
Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products  Food and Drug Administration (FDA) Final
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities  Food and Drug Administration (FDA) Final
Recommended Approaches to Integration of Genetic Toxicology Study Results  Food and Drug Administration (FDA) Final
Recommended Clinical Study Design for Ventricular Tachycardia Ablation  Food and Drug Administration (FDA) Final
Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for Industry  Food and Drug Administration (FDA) Final
Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions  Food and Drug Administration (FDA) Final
Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention  Food and Drug Administration (FDA) Final
Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4048 documents.