BIO375H5 Lecture Notes - Lecture 8: Medtronic, Clinical Trial, Snake Oil
Document Summary
Medtronic: can"t use pma pathway for an app wouldn"t make sense, the icd and app aren"t physically connected so can"t argue both as class 3, have to independently assess the risk class of the app. If you produce a product and it causes risk the fda will point fingers to the manufacturers: even when patients abuse the products impacts the risk class. Clinical trials & risk: perception of risk, risk effects the expectations for investor return, concept of risk, problem: collectively, we have done a poor job identifying drugs that will be successful during clinical testing. Instagram used by younger people: reflected on demographic of user, digital ethnography live online and have digital footprint, psychographic voting habits, religious views, etc. A specific drug or biologic involved in the event: 4. March 12, 2020: social listening inspires and complements market research, 1. Why did patients discontinue otezla treatment: 2. Are patients using otc to manage side effects: 3.
