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jz365 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
One drug that was huge in the early development of modern FDA medicinal regulations was Thalidomide. This drug was popular in the 1960’s and was marketed for morning sickness in pregnant women. Unbeknownst at the time, the enantiomer of the drug was extremely teratogenetic. The FDA refused this drug even though it was approved by countries in Europe. Because of the findings of birth defects linked to this drug, the FDA tightened its security regarding drugs.