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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
Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events  Food and Drug Administration (FDA) Final
Small Entity Compliance Guide: Bottled Water and Residual Disinfectants and Disinfection Byproducts  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing  Food and Drug Administration (FDA) Final
Presenting Risk Information in Prescription Drug and Medical Device Promotion  Food and Drug Administration (FDA) Proposed
Small Entity Compliance Guide: Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and Osteoporosis  Food and Drug Administration (FDA) Final
Labeling OTC Human Drug Products; Small Entity Compliance Guide: Guidance for Industry  Food and Drug Administration (FDA) Final
CPG Sec 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002  Food and Drug Administration (FDA) Final
CVM GFI #195 Small Entities Compliance Guide For Renderers—Substances Prohibited From Use In Animal Food Or Feed  Food and Drug Administration (FDA) Final
Questions and Answers on Current Good Manufacturing Practice Questions and Answers on Current Good Manufacturing Practice Requirements | General Provisions  Food and Drug Administration (FDA) Final
Small Entity Compliance Guide: Declaration by Name on the Label of All Foods and Cosmetic Products that Contain Cochineal Extract and Carmine  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.