BIO375H5 Lecture Notes - Lecture 1: Spinal Muscular Atrophy, New Product Development, Financial Plan
Document Summary
Important issues (abraham. e. yang@gmail. com) +student number n full name (bio375) Npd presentation and critique- new product development based on the presentation, evaluating other group"s presentation. Choose problems on medicine, health, nutrition or fitness. Each team is expected to propose a new biomedical product to solve the problem. Present and write paper for the new product. Cumulative final exam (lectures, required readings and tutorials) Before term test 1: how are we going to develop the biomedical product. After term test 2: 510k and pma for regulatory gateway for biomedical product. Key concepts- the drugs approval table will keep changing, as it always been approved over time. No drug was approved to treat spinal muscular atrophy (sma) in 2016. Swallowable balloon in the stomach (approved by fda) Vr for treating pain (from anxiety and painful treatments) Statistically, not much patients agreed to the treatments, patients do not have much exposure. Single handed inserter for birth control (approved on 2016) newer version.
