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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
Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry  Food and Drug Administration (FDA) Proposed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
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
Using the Inactive Ingredient Database Guidance for Industry  Food and Drug Administration (FDA) Proposed
Validation and Verification of Analytical Testing Methods Used for Tobacco Products  Food and Drug Administration (FDA) Final
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) :  Food and Drug Administration (FDA) Final
Considerations for the Development of Dried Plasma Products Intended for Transfusion: Guidance for Industry  Food and Drug Administration (FDA) Final
Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.