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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
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations  Food and Drug Administration (FDA) Proposed
Translation of Good Laboratory Practice Study Reports: Questions and Answers  Food and Drug Administration (FDA) Proposed
Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry  Food and Drug Administration (FDA) Proposed
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry  Food and Drug Administration (FDA) Proposed
Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry  Food and Drug Administration (FDA) Proposed
Ulcerative Colitis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry  Food and Drug Administration (FDA) Proposed
Upper Facial Lines: Developing Botulinum Toxin Drug Products  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
Use of Data Monitoring Committees in Clinical Trials  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.