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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
Using the Inactive Ingredient Database Guidance for Industry  Food and Drug Administration (FDA) Proposed
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments  Food and Drug Administration (FDA) Proposed
Use of Data Monitoring Committees in Clinical Trials  Food and Drug Administration (FDA) Proposed
Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Upper Facial Lines: Developing Botulinum Toxin Drug Products  Food and Drug Administration (FDA) Proposed
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.