BIO375H5 Study Guide - Midterm Guide: Phases Of Clinical Research, Diethylene Glycol, Otc Markets Group
Document Summary
Massengill company"s elixir, sulfanilamide, for the treatment of sore throats in people with streptococcal infections, drove demand for a palatable form for children. The company chemist added diethylene glycol to sweeten the elixir, without any testing of the new additive: the company tried to make the drug taste better to facilitate children taking it. Diethylene glycol is known as antifreeze today and carries lethal consequences when ingested. As a result, 107 people (mostly children) died before the us food and drug administration was able to gather all of the supplies. This even could have been prevented if the fda existed and enforces the manufacturer to do clinical tests to prove that the additive was not toxic and lethal. Question two fda (food and drug administration) Regulated blood-related biologics and blood substitutes by cber. Regulates diagnostics tests (ivd invitro diagnostics) by oivd.
