(ft. Amelia 醫藥法規顧問)專業和堅持有多重要?這集講述美國FDA審查員,Dr.Frances Oldham Kelsey的故事。1960年，因為她嚴謹審查沙利竇邁(Thalidomide)藥品的上市申請，避免了美國數以千計畸形兒的出生。事後影響美國修法，賦予FDA權力， 整件事的影響持續至今。現今的藥品審查、臨床試驗規範等等也因此衍生出來.. 單集內容👉https://podcast.biomeder.com/episodes/frances-oldham-kelsey-thalidomide (00:01:19) Dr.Frances Oldham Kelsey 介紹 (00:05:43) 沙利竇邁(thalidomide)+申請在美國上市 (00:13:37) 華盛頓郵報的報導 (00:20:08) 美國法案修法，Kefauver-Harris Amendments (00:25:36) 集眾人之力+專業和堅持 留言告訴我你對這一集的想法： https://open.firstory.me/story/ckvhx3zrscn1m0838r1ysr7ka?m=comment ✎ 留言: podcast.biomeder.com/contact-us 🖄 Email: [email protected] 💰 小額支持: biomeder.com/product/pay-to-recognition 《生醫人生旅歷》podcast.biomeder.com 《BioMeder生醫人網摘》biomeder.com 這個節目，由生醫人文化科技製作播出。 Powered by Firstory Hosting
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