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FDA Botanical Drug Development Guidance for Industry

蒋千琴 11/12/2021 浏览 189 FDA US

标准简介

Botanical Drug Development Guidance for Industry[附网盘链接]由Food And Drug Administration于过去发布，适用于US。

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Botanical Drug Development Guidance for Industry[附网盘链接]
Botanical Drug Development Guidance for Industry[附网盘链接](截图)

 

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标准文档类型为Botanical Drug Development 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

Botanical Drug Development 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 describes the Center for Drug Evaluation and Research’s (CDER’s) current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This guidance specifically discusses several areas in which, due to the unique nature of botanical drugs, the Agency finds it appropriate to apply regulatory policies that differ from those applied to nonbotanical drugs, such as synthetic, semi-synthetic, or otherwise highly purified or chemically modified drugs, including antibiotics derived from microorganisms. Because this guidance focuses on considerations unique to botanical drugs, policies and recommendations applicable to both botanical and nonbotanical drugs are generally not covered in this document; readers should refer to other FDA guidance documents for appropriate information. This guidance replaces the Guidance for Industry on Botanical Drug Products issued in June 2

2004. The general approach to botanical drug development has remained unchanged since that time; however, based on improved understanding of botanical drugs and experience acquired in the reviews of NDAs and INDs for these drugs, specific recommendations have been modified and new sections have been added to better address late-phase development and NDA submission for botanical drugs. 1

This guidance has been prepared by a working group composed of staff from the Office of Pharmaceutical Quality, Office of New Drugs, Office of Translational Sciences, and Office of Medical Policy in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

In the Federal Register of August 2015 (80 FR 49240), we issued and sought comment on a draft guidance that revised Botanical Drug Products. This guidance finalizes the August 2015 draft guidance—also entitled Botanical Drug Development—and replaces the June 2004 final guidance. 1

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