8/22付で米国FDA/CDRHから「CDRH Regulatory Science Priorities」と題する、規制科学の優先事項トップ10を概説しています。
トップ10は以下の通りです。
① Leverage “big data” for regulatory decision-making
② Modernize biocompatibility and biological risk evaluation of device materials
③ Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making
④ Advance tests and methods for predicting and monitoring medical device clinical performance
⑤ Develop methods and tools to improve and streamline clinical trial design
⑥ Develop computational modeling technologies to support regulatory decision-making
⑦ Enhance the performance of digital health and medical device cybersecurity
⑧ Reduce healthcare associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices
⑨ Collect and use patient input in regulatory decision-making
⑩ Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis and progression
また本件について、8/22付のRAPSが「CDRH Details Top Regulatory Science Priorities」と題して記事に取り上げています。
医療機器関係者及び興味のある方は、下記URLsのウェブサイト・資料並びにニュース記事をご参照ください。
lウェブサイト「CDRH Regulatory Science Priorities」
https://www.fda.gov/medical-devices/science-and-research-medical-devices/cdrh-regulatory-science-priorities
lpdfファイル「CDRH Regulatory Science Priorities」
https://www.fda.gov/media/130213/download
l8/22付RAPS「CDRH Details Top Regulatory Science Priorities」
https://www.raps.org/news-and-articles/news-articles/2019/8/cdrh-details-top-regulatory-science-priorities
トップ10は以下の通りです。
① Leverage “big data” for regulatory decision-making
② Modernize biocompatibility and biological risk evaluation of device materials
③ Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making
④ Advance tests and methods for predicting and monitoring medical device clinical performance
⑤ Develop methods and tools to improve and streamline clinical trial design
⑥ Develop computational modeling technologies to support regulatory decision-making
⑦ Enhance the performance of digital health and medical device cybersecurity
⑧ Reduce healthcare associated infections by better understanding the effectiveness of antimicrobials, sterilization and reprocessing of medical devices
⑨ Collect and use patient input in regulatory decision-making
⑩ Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis and progression
また本件について、8/22付のRAPSが「CDRH Details Top Regulatory Science Priorities」と題して記事に取り上げています。
医療機器関係者及び興味のある方は、下記URLsのウェブサイト
lウェブサイト「CDRH Regulatory Science Priorities」
https://www.fda.gov/medical-
lpdfファイル「CDRH Regulatory Science Priorities」
https://www.fda.gov/media/
l8/22付RAPS「CDRH Details Top Regulatory Science Priorities」
https://www.raps.org/news-and-
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経歴 ※このプロフィールは掲載記事執筆時点での内容となります
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