BIO375H5 Lecture 5: BIO375- Lecture 5 Notes
Document Summary
The gate you choose to go through depends on the type of product you create (ex: drug, ivd, diagnosis, medical device) Ivd are very similar to medical device one major difference is the clia (clinical laboratory improvement amendment) Previously before 1937, in 1906 they started a fda-like regulatory pathway but it was not as specific or disciplined like the fda (a lot of things got approved that would not be approved today) This situation could have been avoided if the fda was around to supervise every step in the clinical trials/processes. One year after this event, the food and drug act of 1938 more modern version compared to the. 1937 version product needs to be safe before it goes to the market, requires approval by us fda (the gatekeeper) they learned from their mistakes in the previous year. If you want to sell your drug, the drug needs to be approved by health authority health canada is responsible for this.
