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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
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause  Food and Drug Administration (FDA) Proposed
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing  Food and Drug Administration (FDA) Proposed
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5483 documents.