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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
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 Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical Devices  Food and Drug Administration (FDA) Final
Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA: Dear Manufacturer Letter Regarding Food Labeling  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA: Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT Training  Food and Drug Administration (FDA) Final
Guidance for Industry: Implementation of Section 10809 of the Farm Security and Investment Act of 2002 Regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated with Irradiation  Food and Drug Administration (FDA) Final
Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers  Food and Drug Administration (FDA) Final
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