Recently Posted FDA Guidance Documents

8/7/2019 – Fabry Disease: Developing Drugs for Treatment Guidance for Industry [DRAFT]

Issued by: Center for Drug Evaluation and Research

The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that can support the approval of drugs and biological products intended for the treatment of Fabry disease (FD).


7/31/2019 Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry [FINAL]

Issued by: Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the overall development program and clinical trial designs to support the development of topical and systemic drugs and biological products for the treatment of bacterial vaginosis (BV).

This guidance focuses on considerations that are specific to BV drug development. This guidance does not contain discussion of the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials (September 1998) and E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001), respectively.


7/31/2019 E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES [DRAFT]

Issued by: Center for Drug Evaluation and Research

Clinical studies of medical interventions are conducted to provide information that can ultimately improve access to safe and effective drugs with a meaningful impact on patients while protecting those participating in the studies. This document focuses on designing quality into clinical studies, considering the diversity of clinical study designs and data sources used to support regulatory and other health policy decisions.


7/31/2019 Uncomplicated Urinary Tract Infections: Developing Drugs for TreatmentGuidance for Industry [FINAL]

Issued by: Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated urinary tract infections (uUTIs). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for the treatment of uUTIs.


7/31/2019 Vulvovaginal Candidiasis: Developing Drugs for Treatment [FINAL]

Issued by: Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the overall clinical development program and clinical trial designs to support drugs for treating vulvovaginal candidiasis (VVC).

In general, this guidance focuses only on treating VVC. This guidance does not discuss clinical development programs focused on preventing or reducing the recurrence of VVC. Sponsors should discuss the clinical development of such programs with the FDA.

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