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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs  Food and Drug Administration (FDA) Proposed
E19 OPTIMISATION OF SAFETY DATA COLLECTION  Food and Drug Administration (FDA) Proposed
E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES  Food and Drug Administration (FDA) Proposed
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials  Food and Drug Administration (FDA) Proposed
eCTD v4.0 Implementation Package DRAFT Specification for Submission Formats v2.0  Food and Drug Administration (FDA) Proposed
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry  Food and Drug Administration (FDA) Proposed
Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry   Food and Drug Administration (FDA) Proposed
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry  Food and Drug Administration (FDA) Proposed
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
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