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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation  Food and Drug Administration (FDA) Proposed
Endogenous Cushing’s Syndrome: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Voluntary Sodium Reduction Goals (Edition 2)  Food and Drug Administration (FDA) Proposed
Evaluation of Therapeutic Equivalence  Food and Drug Administration (FDA) Proposed
Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome Instrument for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Voluntary Disclosure of Sesame as an Allergen  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
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