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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
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention  Food and Drug Administration (FDA) Proposed
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information  Food and Drug Administration (FDA) Proposed
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products  Food and Drug Administration (FDA) Proposed
Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics  Food and Drug Administration (FDA) Proposed
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance…  Food and Drug Administration (FDA) Proposed
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration…  Food and Drug Administration (FDA) Proposed
The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 11384 documents.