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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
Multiple Endpoints in Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation: Guidance for Industry  Food and Drug Administration (FDA) Final
National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions – Small Entity Compliance Guide: Guidance for Industry  Food and Drug Administration (FDA) Final
New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination: Guidance for Industry  Food and Drug Administration (FDA) Final
Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment : Guidance for Industry  Food and Drug Administration (FDA) Final
Notifying FDA of Fatalities Related to Blood Collection or Transfusion: Guidance for Industry  Food and Drug Administration (FDA) Final
Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry: Guidance for Industry  Food and Drug Administration (FDA) Final
On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test: Guidance for Industry  Food and Drug Administration (FDA) Final
Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.