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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 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
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry  Food and Drug Administration (FDA) Final
Reformulating Drug Products That Contain Carbomers Manufactured With Benzene  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.