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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
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
Orally Disintegrating Tablets: Guidance for Industry  Food and Drug Administration (FDA) Final
Orange Book Questions and Answers Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use —: Guidance for Industry  Food and Drug Administration (FDA) Final
Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring: Guidance for Industry  Food and Drug Administration (FDA) Final
PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.