FDA Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases

标准简介

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于美国。

标准截图

 

标准文档说明

标准文档类型为Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to assist sponsors in the clinical development of new antibacterial 2

drugs. Specifically, the guidance explains the FDA’s current thinking about possible streamlined development programs and clinical trial designs for antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need, including patients who have a 3

serious bacterial disease for which effective antibacterial drugs are limited or lacking. Antibacterial drugs that are pathogen-focused can be developed for the treatment of serious 4,5

bacterial diseases in patients who have an unmet medical need. 1

This guidance has been prepared by the Division of Anti-Infective Products in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products regulated in CDER unless otherwise specified. 3

For example, effective antibacterial drugs can be limited because resistance to several antibacterial drugs has developed. Patients who have allergies or intolerance to several antibacterial drugs also may be considered as having an unmet medical need. See the guidance for industry Expedited Programs for Serious Conditions — Drugs and Biologics, section III.C., Unmet Medical Need. We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 4

Given the wide range of meanings associated with the terms pathogen-focused, pathogen-specific, organism-

specific, or pathogen-based antibacterial drugs, we recommend that sponsors provide a clear description of their proposed drug development program. For purposes of general discussion in this guidance, the term pathogen-

focused antibacterial drug refers to a drug active against only a single species or few species within a genus of bacteria. 5

For a detailed discussion of regulatory programs intended to streamline or expedite development and review of drugs (e.g., fast track, breakthrough) and their attendant criteria and definitions, see the guidance for industry Expedited Programs for Serious Conditions –– Drugs and Biologics. 1

网盘链接

百度网盘：https://pan.baidu.com/s/1XXt25khmFBvd5R6OxjPVpg
提取码：79ff