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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
Benefit-Risk Considerations for Product Quality Assessments  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application  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
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet  Food and Drug Administration (FDA) Proposed
Certification Process of Designated Medical Gases  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Chinese Translation of Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry Edition 2 (关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答 2010年5月)  Food and Drug Administration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
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.