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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
"Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications"  Food and Drug Administration (FDA) Final
(Potassium Iodide) KI in Radiation Emergencies-Questions and Answers  Food and Drug Administration (FDA) Final
1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers  Food and Drug Administration (FDA) Final
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day  Food and Drug Administration (FDA) Final
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Abuse-Deterrent Opioids-Evaluation and Labeling  Food and Drug Administration (FDA) Final
Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment  Food and Drug Administration (FDA) Final
Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment  Food and Drug Administration (FDA) Final
Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment  Food and Drug Administration (FDA) Final
Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.