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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
Use of Investigational Products When Subjects Enter a Second Institution: Guidance for Institutional Review Boards and Clinical Investigators  Food and Drug Administration (FDA) Final
Guidance for Industry: Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy  Food and Drug Administration (FDA) Final
Guidance for Industry and Other Stakeholders: Redbook 2000 : Toxicological Principles for the Safety Assessment of Food Ingredients  Food and Drug Administration (FDA) Final
REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for Industry  Food and Drug Administration (FDA) Final
"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
This Guidance Portal contains 4735 documents.