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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
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
Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology: Guidance for Industry  Food and Drug Administration (FDA) Final
Container Closure Systems for Packaging Human Drugs and Biologics: Guidance for Industry  Food and Drug Administration (FDA) Final
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Consumer-Directed Broadcast Advertisements: Guidance for Industry  Food and Drug Administration (FDA) Final
Consumer Antiseptic Wash Final Rule Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.