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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
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products  Food and Drug Administration (FDA) Proposed
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001  Food and Drug Administration (FDA) Proposed
Considerations for Rescinding Breakthrough Therapy Designation  Food and Drug Administration (FDA) Proposed
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
Applications Covered by Section 505(b)(2)  Food and Drug Administration (FDA) Proposed
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry  Food and Drug Administration (FDA) Proposed
Benefit-Risk Considerations for Product Quality Assessments  Food and Drug Administration (FDA) Proposed
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3999 documents.