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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications  Food and Drug Administration (FDA) Proposed
CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies  Food and Drug Administration (FDA) Proposed
CVM GFI #290 (VICH GL61) – Pharmaceutical Development  Food and Drug Administration (FDA) Proposed
Development of a Shared System REMS Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations  Food and Drug Administration (FDA) Proposed
Orientación preliminar de la industria: Preguntas y respuestas sobre el Registro de productos sanitarios en productos agroalimentarios, según establecido por la Ley de Enmiendas a la Alimentación y Medicamentos (FDA), 2007 (Edición 2)  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3312 documents.

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