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.

中文翻译：

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《信息自由法》访问正在研究的新药申请。

我们报告了我们与美国食品和药物管理局（FDA）合作的经验，以便获得霍夫曼·拉·罗氏（Hoffman-La Roche，Inc.）向该机构提交的废弃试验性新药（IND）申请和后续申请文件的访问权限。与其他人的经验相反，根据我们的具体要求，FDA提供了IND申请号和464页相关材料，包括该机构的初步药理学审查以及包括研究药物手册，临床研究方案和修正案的年度报告。并详细介绍药物治疗的临床经验。