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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
Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions  Food and Drug Administration (FDA) Proposed
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry  Food and Drug Administration (FDA) Final
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
Statistical Approaches to Establishing Bioequivalence  Food and Drug Administration (FDA) Proposed
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals  Food and Drug Administration (FDA) Proposed
Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999  Food and Drug Administration (FDA) Proposed
Stimulant Use Disorders: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Submission of Quality Metrics Data Guidance for Industry  Food and Drug Administration (FDA) Proposed
Submitting Debarment Certification Statements  Food and Drug Administration (FDA) Proposed
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.