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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
Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use  Food and Drug Administration (FDA) Final
Policy on Lamp Compatibility (sunlamps)  Food and Drug Administration (FDA) Final
Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp Products  Food and Drug Administration (FDA) Final
Policy on Warning Label Required on Sunlamp Products  Food and Drug Administration (FDA) Final
Possible Dioxin/PCB Contamination of Drug and Biological Products  Food and Drug Administration (FDA) Final
Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry  Food and Drug Administration (FDA) Final
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic  Food and Drug Administration (FDA) Final
Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application  Food and Drug Administration (FDA) Final
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report  Food and Drug Administration (FDA) Final
Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.