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《信息自由法》对研究性新药申请的获取。

Freedom of Information Act Access to an Investigational New Drug Application.

作者信息

Southall Noel T

机构信息

National Center for Advancing Translational Sciences, National Institutes of Health, 9800 Medical Center Drive, Rockville, Maryland 20850, United States.

出版信息

ACS Pharmacol Transl Sci. 2019 Aug 20;2(6):497-500. doi: 10.1021/acsptsci.9b00056. eCollection 2019 Dec 13.

DOI:10.1021/acsptsci.9b00056
PMID:32259081
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7089016/
Abstract

We report our experience working with the US Food and Drug Administration (FDA) to obtain access to an abandoned investigational new drug (IND) application and subsequent application documents submitted by Hoffman-La Roche, Inc. to the agency. Contrary to others' experience and in response to our specific request, FDA provided the IND application number and 464 pages of relevant material, including the initial pharmacology review by the agency and an annual report consisting of an investigational drug brochure, clinical study protocol and amendments and detailing clinical experience with drug treatment. It may be possible to bring application files of additional drugs previously submitted to the agency into the public record to help bolster repurposing efforts and realize our shared public interest in benefiting from previous human clinical studies.

摘要

我们报告了与美国食品药品监督管理局（FDA）合作获取一份废弃的研究性新药（IND）申请以及霍夫曼-罗氏公司随后提交给该机构的申请文件的经历。与其他人的经历不同，应我们的特定请求，FDA提供了IND申请编号和464页相关材料，包括该机构的初始药理学审查以及一份年度报告，该报告包含一份研究性药物手册、临床研究方案及修正案，并详细说明了药物治疗的临床经验。有可能将之前提交给该机构的其他药物的申请文件纳入公共记录，以帮助加强药物重新利用的努力，并实现我们从以往人体临床研究中受益的共同公共利益。