Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products  Food and Drug Administration (FDA) Proposed
Sameness Evaluations in an ANDA — Active Ingredients  Food and Drug Administration (FDA) Proposed
Sample formats for Form FDA 356h_2011  Food and Drug Administration (FDA) Proposed
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations  Food and Drug Administration (FDA) Proposed
SPL Standard for Content of Labeling Technical Qs & As  Food and Drug Administration (FDA) Proposed
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry  Food and Drug Administration (FDA) Proposed
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
This Guidance Portal contains 4741 documents.