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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
Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs  Food and Drug Administration (FDA) Proposed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Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance: Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06  Food and Drug Administration (FDA) Proposed
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in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula  Food and Drug Administration (FDA) Proposed
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products  Food and Drug Administration (FDA) Proposed
Risk Management Plans to Mitigate the Potential for Drug Shortages  Food and Drug Administration (FDA) Proposed
Rheumatoid Arthritis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
Sameness Evaluations in an ANDA — Active Ingredients  Food and Drug Administration (FDA) Proposed
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5483 documents.