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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
Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Development of New Stereoisomeric Drugs  Food and Drug Administration (FDA) Final
Device Labeling Guidance #G91-1 (Blue Book Memo)  Food and Drug Administration (FDA) Final
Drug Master Files: Guidelines  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
French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler)  Food and Drug Administration (FDA) Final
French Translation of Guidance for Industry: Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal (Soumission d’un rapport concernant plusieurs usines auprès du portail électronique d’enregistrement des denrées…  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
This Guidance Portal contains 4741 documents.