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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
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection  Food and Drug Administration (FDA) Proposed
Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
General Considerations for the Use of New Approach Methodologies in Drug Development  Food and Drug Administration (FDA) Proposed
Bioanalytical Method Validation for Biomarkers  Food and Drug Administration (FDA) Final
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing  Food and Drug Administration (FDA) Proposed
Establishing Impurity Specifications for Antibiotics  Food and Drug Administration (FDA) Proposed
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application: Guidance for Industry  Food and Drug Administration (FDA) Final
Submitting Continuous Glucose Monitoring Data in Clinical Trials  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4112 documents.