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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
Pharmacogenomic Data Submissions  Food and Drug Administration (FDA) Proposed
Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Labeling for Combined Hormonal Contraceptives Guidance for Industry  Food and Drug Administration (FDA) Proposed
Labeling for Biosimilar and Interchangeable Biosimilar Products  Food and Drug Administration (FDA) Proposed
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards  Food and Drug Administration (FDA) Proposed
CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use  Food and Drug Administration (FDA) Proposed
CVM GFI #290 (VICH GL61) – Pharmaceutical Development  Food and Drug Administration (FDA) Proposed
CVM GFI #292 Chemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles  Food and Drug Administration (FDA) Proposed
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data  Food and Drug Administration (FDA) Proposed
Development of a Shared System REMS Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5497 documents.