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FDA Epidermolysis Bullosa Developing Drugs for Treatment of Cutaneous Manifestations;

蒋千琴 4/4/2022 浏览 236 FDA U.S

标准简介

Epidermolysis Bullosa Developing Drugs for Treatment of Cutaneous Manifestations;[附网盘链接]是FDA于过去发布的FDA标准，适用于U.S。

标准截图

Epidermolysis Bullosa Developing Drugs for Treatment of Cutaneous Manifestations;[附网盘链接]
Epidermolysis Bullosa Developing Drugs for Treatment of Cutaneous Manifestations;[附网盘链接](截图)

 

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标准部分原文

Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations 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 2

The purpose of this guidance is to assist sponsors with the development of drugs for treatment or prevention of the serious cutaneous manifestations of the heterogeneous group of disorders 3

collectively known as epidermolysis bullosa (EB). The paucity of effective treatment options for EB represents an important unmet medical need. This guidance focuses on drug development and trial design issues specific to the treatment of EB, including FDA’s current thinking on trial endpoints. There is not yet sufficient clinical trial experience to establish definitive endpoints. FDA strongly encourages sponsors to meet with the appropriate review division in early planning stages for information tailored to each drug development program. General issues, such as the efficacy evidence needed to support approval for serious and life-

threatening diseases or approaches to adaptive study design, are discussed in guidances for 1

This guidance has been prepared by the Division of Dermatology and Dental Drug Products and by the Rare Diseases Program in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics 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 unless otherwise specified. 3

See the guidance for industry Expedited Programs for Serious Conditions — Drugs and Biologics (May 2014). We update guidances periodically. 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.

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