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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
Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines: Guidance for Industry  Food and Drug Administration (FDA) Final
Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines: Guidance for Industry  Food and Drug Administration (FDA) Final
Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics: Guidance for Industry  Food and Drug Administration (FDA) Final
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry  Food and Drug Administration (FDA) Final
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry  Food and Drug Administration (FDA) Final
Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco: Guidance for Industry  Food and Drug Administration (FDA) Final
Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.