BIO375H5 Lecture 5: lecture 5 BIO375 - Regulatory gateway
Document Summary
There are many different gates you need to go thru to please the fda. Because, before 1937, there was no gatekeeper (fda). Note - there technically was a gatekeeper before 1937: in the us, around 1906, there was the food and drug act, but it was not specific enough. It didn"t have specific procedures (phase i-iv). tried to add diethylene glycol to make the drug taste better. This was an anti-freezing agent this deemed to be lethal to the children. This could"ve been prevent if something such as the fda were to be put in place to control the gates and regulate. 1938 a year after, the food and drug act was modified to be more modern. This is not the same as the one from 1906. Ex; children died after receiving treatment to treat sore throat. If your drug wants to get to the market it needs to go thru the fda.
