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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
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
Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff  Food and Drug Administration (FDA) Final
Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers  Food and Drug Administration (FDA) Final
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics  Food and Drug Administration (FDA) Final
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry  Food and Drug Administration (FDA) Final
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Final
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.