FDA Anthrax Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry

标准简介

Anthrax Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry[附网盘链接]由Food&Drug Administration于当前发布，适用于U.S。

标准截图

 

标准文档说明

标准文档类型为Anthrax Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry[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

Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax 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 The purpose of this guidance is to assist sponsors in the development of drugs for the indication of prophylaxis of inhalational anthrax in persons who have or may have inhaled aerosolized 2

Bacillus anthracis spores but who have not yet manifested clinical evidence of disease. The indication also applies to persons with anticipated exposure to B. anthracis spores (e.g., first responders for anthrax incidents); in such cases, initiation of antibacterial therapy would begin immediately before entering the B. anthracis-contaminated environment. For more information regarding the indication, see section II.B., Indication for Prophylaxis of Inhalational Anthrax. This guidance clarifies that drugs developed for the prophylaxis of inhalational anthrax are to be 3

considered for approval under the animal rule. 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 1

This guidance has been prepared by the Division of Anti-Infective Products in the Center for Drug Evaluation and Research 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 such as therapeutic proteins and monoclonal antibodies, unless otherwise specified, and references to approval include new drug application approval for drugs or biologics license application licensure for therapeutic proteins and monoclonal antibodies. Sponsors interested in developing other types of biological products, such as vaccines and immunoglobulin preparations, should contact the appropriate review division in the Center for Biologics Evaluation and Research. 3

The animal rule sets forth a pathway for approval of drug or biological products when human efficacy studies are not ethical or feasible. See 21 CFR part 314, subpart I, for drugs and 21 CFR part 601, subpart H, for biological products. See also the guidance for industry Product Development Under the Animal Rule. We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.

网盘链接

百度网盘：https://pan.baidu.com/s/1ZKYhvSinb482694ceFEgWA
提取码：udy1