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manolo replied to the topic Drugs banned in US but not in other countries in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago
In the 1950s there was a pharmaceutical company (Chemie Grunenthal) created sleeping pills from thalidomide. It was advertised as safe for everyone to use, including pregnant and nursing mothers. The drug gained popularity fairly quickly and spread from West Germany into the UK.
The company also wanted to sell the drug in the US, but Dr. Frances Oldham Kelsey continually denied them. She didn’t believe there was enough data to back the claims that the company was making. In the early 1960s, it was discovered that the drug was teratogenic (causes issues in fetal development).