Topic > Thalidomide essay - 569

the reporting type. For example; summary statistics of reports from foreign and domestic countries, summary statistics of reports from healthcare professionals and consumers, and summary statistics by manufacturer. In the year 1962, the Kefauver-Harris Drug Amendment Act was established. The law states that all drugs must be subjected to close surveillance during clinical trials and also after the drug is marketed. The clinical trial must provide data demonstrating that the drug is safe and effective before it is marketed. This act was established after the thalidomide tragedy that occurred in the 1960s. In the 1960s, thalidomide became a very popular sleep medication, just like when aspirin was first discovered. Thalidomide was marketed in 46 countries and was sold over the counter. During that time, the drug was said to be safe for pregnant women. An Australian obstetrician, named Dr. William McBride, began observing high levels of morning sickness in pregnant women caused by the drug Thalidomide. Then, when he gave birth to many children with serious infantile defects, he realized that t...