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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
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products  Food and Drug Administration (FDA) Proposed
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs  Food and Drug Administration (FDA) Proposed
Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products  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
Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products  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
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention  Food and Drug Administration (FDA) Proposed
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.