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eSubmission of Promotional Labeling and Advertising Materials via the eCTD FDA Gateway
Therapeutic Innovation & Regulatory Science ( IF 2.0 ) Pub Date : 2020-05-27 , DOI: 10.1007/s43441-020-00166-8
Joanne Hathaway 1 , Kevin Hom 1 , Boris Reznichenko 1 , Kousalya Vaddempudi 1 , Albert D'Alonzo 1
Affiliation  

In June 2019, the Food and Drug Administration (FDA) issued its final Guidance on submission of advertising and promotional materials to the Office of Prescription Drug Promotion (OPDP) in eCTD format through the electronic gateway. Our goal was to put in place a stepwise plan and clear process to submit these materials in advance of June 2021 when electronic submissions become mandatory. The first step was to test every submission type and every possible iteration, therefore, as issues arose, problems could be easily addressed and resolved. This helped build confidence and achieve a level of comfort in preparing for the first eSubmission. To accomplish this, testing was performed through the gateway including: Form FDA 2253 (and accompanying promotional materials), advisory comments (launch and non-launch), enforcement actions, multiproduct submissions (grouped and ungrouped), and information request responses. The second step was to obtain internal alignment between involved functional areas to pilot a single brand. Finally, after a successful pilot program, eCTD submissions were expanded across all other brands. This paper discusses the stepwise approach taken, considerations for electronic submissions and results for improved efficiencies and cost savings. Implementing a well, laid-out plan, and starting the conversion early, allowed us to be thoughtful in our approach. The steps taken, and the successful outcomes achieved, demonstrate that there is no reason to wait for submitting promotional materials via the FDA gateway.

中文翻译:

通过 eCTD FDA 网关电子提交促销标签和广告材料

2019 年 6 月,美国食品药品监督管理局 (FDA) 发布了关于通过电子网关以 eCTD 格式向处方药推广办公室 (OPDP) 提交广告和宣传材料的最终指南。我们的目标是制定逐步计划和明确的流程,以便在 2021 年 6 月电子提交成为强制性要求之前提交这些材料。第一步是测试每个提交类型和每个可能的迭代,因此,当出现问题时,可以轻松解决和解决问题。这有助于在准备第一次电子提交时建立​​信心并达到一定程度的舒适度。为此,通过网关进行了测试,包括:FDA 2253 表格(以及随附的宣传材料)、咨询意见(发布和未发布)、执法行动、多产品提交(分组和未分组),以及信息请求响应。第二步是获得相关功能区域之间的内部对齐,以试点单一品牌。最后,在试点项目成功后,eCTD 提交范围扩大到所有其他品牌。本文讨论了所采用的逐步方法、电子提交的注意事项以及提高效率和节约成本的结果。实施一个精心设计的计划并尽早开始转换,使我们能够在我们的方法中考虑周到。所采取的步骤和取得的成功结果表明,没有理由等待通过 FDA 网关提交宣传材料。第二步是获得相关功能区域之间的内部对齐,以试点单一品牌。最后,在成功的试点计划之后,eCTD 提交范围扩展到所有其他品牌。本文讨论了所采用的逐步方法、电子提交的注意事项以及提高效率和节约成本的结果。实施一个精心设计的计划并尽早开始转换,使我们能够在我们的方法中考虑周到。所采取的步骤和取得的成功结果表明,没有理由等待通过 FDA 网关提交宣传材料。第二步是获得相关功能区域之间的内部对齐,以试点单一品牌。最后,在试点项目成功后,eCTD 提交范围扩大到所有其他品牌。本文讨论了所采用的逐步方法、电子提交的注意事项以及提高效率和节约成本的结果。实施一个精心设计的计划并尽早开始转换,使我们能够在我们的方法中考虑周到。所采取的步骤和取得的成功结果表明,没有理由等待通过 FDA 网关提交宣传材料。考虑电子提交和结果以提高效率和节省成本。实施一个精心设计的计划并尽早开始转换,使我们能够在我们的方法中考虑周到。所采取的步骤和取得的成功结果表明,没有理由等待通过 FDA 网关提交宣传材料。考虑电子提交和结果以提高效率和节省成本。实施一个精心设计的计划并尽早开始转换,使我们能够在我们的方法中考虑周到。所采取的步骤和取得的成功结果表明,没有理由等待通过 FDA 网关提交宣传材料。
更新日期:2020-05-27
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