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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
Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs  Food and Drug Administration (FDA) Proposed
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CPG Sec 550.050 (Draft) Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A Toxin  Food and Drug Administration (FDA) Proposed
Certification Process for Designated Medical Gases: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  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Chinese Translation of Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答 2010年5月)  Food and Drug Administration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
CPG Sec 575.100 Draft Revision - Pesticide Chemical Residues in Food - Enforcement Criteria  Food and Drug Administration (FDA) Proposed
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet  Food and Drug Administration (FDA) Proposed
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4128 documents.