BIO375H5 Lecture Notes - Lecture 5: Diethylene Glycol, Good Laboratory Practice, Dangerous Goods
Document Summary
The pathway (gate) depends on the drug, ivd, medical device. Todays focus is the drug and the medical device. The medical device and ivd are very similar but there is one significant difference (clinical improvement. The fda and its role and significance for biomedical product development. The drug makers are required to show that their products were safe before they went on the market. This created the regulatory pathway that was used to test the npd before being approved by the fda. Example: doing animal testing prior to human testing. Laws that are passed by the congress relating to food and drugs safety are written in regulations and interpreted and enforced by the us fda. Us federal law and regulations (box 20 (pg 168)) The laws passed by the congress are usually generalized so you can address the issue in a way that can be consistently applied to all instances with the issue.
