FDA Development of Anti-Infective Drug Products for the Pediatric Population Draft

标准简介

标准截图

标准文档说明

标准部分原文

Draft — Not for Implementation 1 Development of Anti-Infective Drug Products 2 for the Pediatric Population 1

3 Guidance for Industry 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 I. INTRODUCTION 16 17 The purpose of this guidance is to provide general recommendations on the development of anti-

2

18 infective drug products for the pediatric population. 19 20 FDA encourages sponsors to discuss their initial pediatric study plans (iPSPs) for anti-infective 21 drug products with the Agency early and, in most instances, no later than 60-calendar days after 3

22 the end-of-phase 2 meeting. 23 24 This guidance does not address the full scope of considerations for pediatric anti-infective drug 4

25 product development. Additional information is available in several guidances for industry. This 26 guidance does not apply to preventative vaccines. Please note that the general principles set forth 27 in this guidance apply to drugs and biologics. However, because of the complexity and limited 28 experience with some biological products regulated by the Center for Biologics Evaluation and 29 Research (CBER) (e.g., cellular and gene therapies, and phage therapies), there may be 30 additional development considerations. In such cases, CBER encourages sponsors to reach out to 31 the applicable review division, as appropriate. 1

This guidance has been prepared by the Division of Anti-Infectives in the Center for Drug Evaluation and Research, in cooperation with the Center for Biologics Evaluation and Research (CBER), at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drug products include human drugs unless otherwise specified. Sponsors are encouraged to discuss individual drug product differences with the Division of Anti-Infectives or the applicable review division in CBER during drug product development. 3

See the draft guidance for industry Pediatric Study plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans (March 2016). When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 4

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/regulatory-information/search-fda-guidance-documents.

网盘链接

百度网盘：https://pan.baidu.com/s/1i61xmlSWXHIwmmIVq_D_dw
提取码：h7fy