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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Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
General Considerations for the Use of New Approach Methodologies in Drug Development  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Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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
Proposed Rule: Medicaid Program: Prohibition on Federal Medicaid and Childrens Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children  Centers for Medicare & Medicaid Services (CMS) Proposed
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries  Food and Drug Administration (FDA) Proposed
Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4132 documents.