研究

On January 23, 2024, the Platform for Research and Inspiration in Regulatory Science invited former FDA official E. Dennis Bashaw, PharmD, who is currently a regulatory consultant in clinical pharmacology at Bashaw Consulting LLC, to discuss the evolution of drug labeling from the 1980s to the present. He also elaborated on the implementation of the FDA Physician Labeling Rule and the promotion of related drug safety information. This presentation explored the historical development and future trends of FDA drug labeling. Early labels were complicated and difficult to understand, and as information technology advanced, the labels became more complex but lacked effective risk communication. Through a series of rules and guidelines, the FDA has standardized the structure of drug labels to enhance clarity and better convey risk information. In the future, the FDA will promote simplified formats to provide clearer medication guidance and further improve patient safety. By continually optimizing labeling, the FDA ensures that the benefits and risks of drugs are effectively communicated to healthcare professionals and patients.

2024年1月23日，國際藥政法規科學研究平台邀請前美國FDA官員E. Dennis Bashaw (PharmD)，現任Bashaw Consulting LLC 臨床藥理法規顧問，深入討論藥品仿單從1980年代至今的演變，並闡述FDA實施之Physician Labeling Rule與對外提倡相關的用藥安全資訊。本演講探討了FDA藥品仿單的歷史演變及未來發展。早期仿單內容繁瑣且不易理解，隨著信息技術進步，仿單逐漸變得複雜但欠缺風險傳達的有效性。美國FDA透過一系列的規則與指引，標準化了藥品仿單架構，提升了信息清晰度，更好地傳遞風險信息。未來，FDA將推動以簡化格式提供更清晰的用藥指導，進一步提升患者用藥安全。透過不斷優化仿單，確保藥品益處與風險能夠有效傳達給醫療人員及患者。

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活動剪影