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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
Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants  Food and Drug Administration (FDA) Proposed
ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Alcoholism: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Benefit-Risk Considerations for Product Quality Assessments  Food and Drug Administration (FDA) Proposed
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet  Food and Drug Administration (FDA) Proposed
Chinese Translation of Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答 2010年5月)  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance  Food and Drug Administration (FDA) Proposed
Attachement - Qualification Process for Drug Development Tools: Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive…  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 11397 documents.