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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
Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route  Food and Drug Administration (FDA) Final
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients  Food and Drug Administration (FDA) Final
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry  Food and Drug Administration (FDA) Final
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials  Food and Drug Administration (FDA) Final
Nonprescription Sunscreen Drug Products – Format and Content of Data Submissions  Food and Drug Administration (FDA) Final
Nonprescription Sunscreen Drug Products – Safety and Effectiveness Data  Food and Drug Administration (FDA) Final
Nonproprietary Naming of Biological Products Guidance for Industry  Food and Drug Administration (FDA) Final
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment  Food and Drug Administration (FDA) Final
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry  Food and Drug Administration (FDA) Final
Open Door Operation of Microwave Ovens as a Result of Oven Miswiring  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.