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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
Preguntas y respuestas sobre el Registro de incidentes sanitarios en productos agroalimentarios, según lo establecido por la Ley de Enmiendas de la Administración de Medicamentos y Alimentos de 2007  Food and Drug Administration (FDA) Final
Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances  Food and Drug Administration (FDA) Final
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients  Food and Drug Administration (FDA) Final
Questions and Answers on Current Good Manufacturing Practice Questions and Answers on Current Good Manufacturing Practice Requirements | General Provisions  Food and Drug Administration (FDA) Final
Questions and Answers on Current Good Manufacturing Practices for Drugs  Food and Drug Administration (FDA) Final
Real World Data / Real World Evidence RWD/RWE  Food and Drug Administration (FDA) Final
Redbook 2000: I Introduction  Food and Drug Administration (FDA) Final
Redbook 2000: III Recommended Toxicity Studies  Food and Drug Administration (FDA) Final
Redbook 2000: IV. A. Introduction to Guidelines for Toxicity Studies  Food and Drug Administration (FDA) Final
Redbook 2000: IV.B.1. General Guidelines for Designing and Conducting Toxicity Studies  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.