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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
CPG Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11  Food and Drug Administration (FDA) Final
CPG Sec. 420.500 Interference with Compendial Tests  Food and Drug Administration (FDA) Final
CPG Sec. 460.700 Controlled Release Dosage Form Drugs - Rate of Release of Active Ingredients  Food and Drug Administration (FDA) Final
Formas posológicas orales sólidas de liberación inmediata Cambios de escala y posteriores a la aprobación: documentación química, de fabricación y controles, de pruebas de disolución in vitro y bioequivalencia in vivo.  Food and Drug Administration (FDA) Final
Guía para la Industria:  Formas de dosificación oral de liberación prolongada: elaboración, evaluación y aplicación de correlaciones in vitro/in vivo  Food and Drug Administration (FDA) Final
Guía para la Industria:  Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata.  Food and Drug Administration (FDA) Final
Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients  Food and Drug Administration (FDA) Final
CHAPTER 48 - 7348.809 Bioresearch Monitoring  Food and Drug Administration (FDA) Final
Chapter 48 7348.809A Radioactive Drug Research Committee  Food and Drug Administration (FDA) Final
Compliance Policy Guide Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs)  Food and Drug Administration (FDA) Final
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