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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
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers : Guidance for Industry  Food and Drug Administration (FDA) Final
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for Industry  Food and Drug Administration (FDA) Final
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application: Guidance for Industry  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4735 documents.