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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
Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products  Food and Drug Administration (FDA) Proposed
Postoperative Nausea and Vomiting: Developing Drugs for Prevention  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance: Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06  Food and Drug Administration (FDA) Proposed
Q3C: Appendix 4  Food and Drug Administration (FDA) Proposed
Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q1B Photostability Testing of New Drug Substances and Products  Food and Drug Administration (FDA) Proposed
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products  Food and Drug Administration (FDA) Proposed
Public Availability of Labeling Changes in "Changes Being Effected" Supplements  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Presenting Risk Information in Prescription Drug and Medical Device Promotion  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4132 documents.