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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs  Food and Drug Administration (FDA) Final
CPG Sec. 425.400 Computerized Drug Processing; Input/Output Checking  Food and Drug Administration (FDA) Final
CPG Sec. 425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control Records  Food and Drug Administration (FDA) Final
CPG Sec. 430.200 Repacking of Drug Products - Testing/Examination under CGMPs  Food and Drug Administration (FDA) Final
CPG Sec. 430.300 Labeling Shipping Containers of Drugs  Food and Drug Administration (FDA) Final
CPG Sec. 430.400 Urinary Preparations - Misbranding - Lack of Rx Legend and Claims  Food and Drug Administration (FDA) Final
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) Guidance for Industry  Food and Drug Administration (FDA) Final
FDA's Strategy on Antimicrobial Resistance - Questions and Answers  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: Evaluación de la inocuidad de los cultivos alimentarios para el consumo humano afectados por las inundaciones  Food and Drug Administration (FDA) Final
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