這集是Amelia和Yuchin來聊天，解析一封FDA發出的警告信(Warning Letter)的內容。 醫材公司，各種公開的影音資訊和公司網站內容，真的很關鍵啊!! FDA 審查員在進行查核（inspection）前，一定會檢視並存檔公司的網站內容。因此，公司在網站上所發布的任何產品資訊、功能描述或宣稱，都必須與其獲准上市的範圍及科學驗證的結果保持一致。即便產品本身技術強大，也只能宣稱經科學驗證且已獲得批准的範圍，而非所有潛在功能。未經批准的誇大宣稱，將被視為確鑿證據，促使 FDA 要求產品必須按照醫療器材標準進行管理與驗證。 這集內容中的 Warning Letter 留言告訴我你對這一集的想法： https://open.firstory.me/user/ckssiau1vq5ic082295g8on9d/comments ✎ 留言: podcast.biomeder.com/contact-us 📧 Email: [email protected] 《生醫人生旅歷》podcast.biomeder.com 《BioMeder生醫人網摘》biomeder.com Powered by Firstory Hosting
No persons identified in this episode.
This episode hasn't been transcribed yet
Help us prioritize this episode for transcription by upvoting it.
Popular episodes get transcribed faster
Other recent transcribed episodes
Transcribed and ready to explore now
Before the Crisis: How You and Your Relatives Can Prepare for Financial Caregiving
06 Dec 2025
Motley Fool Money
OpenAI's Code Red, Sacks vs New York Times, New Poverty Line?
06 Dec 2025
All-In with Chamath, Jason, Sacks & Friedberg
OpenAI's Code Red, Sacks vs New York Times, New Poverty Line?
06 Dec 2025
All-In with Chamath, Jason, Sacks & Friedberg
Anthropic Finds AI Answers with Interviewer
05 Dec 2025
The Daily AI Show
#2423 - John Cena
05 Dec 2025
The Joe Rogan Experience
Warehouse to wellness: Bob Mauch on modern pharmaceutical distribution
05 Dec 2025
McKinsey on Healthcare