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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
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
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies  Food and Drug Administration (FDA) Final
Potassium Iodide Tablets - Shelf Life Extension  Food and Drug Administration (FDA) Final
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Small Entity Compliance Guide)  Food and Drug Administration (FDA) Final
Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.