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  • myton replied to the topic Thalidomide's Impact on Regulation and the FDA in the forum Introduction to Project Management 8 years, 10 months ago

    The thalidomide disaster established a standard of how much testing must be performed before a product must be released. It builds integrity within the safety of the product, making sure that people are not negatively affected by the medicine. The Thalidomide disaster may have changed the course of the medical device regulation, however, there are more events that have happened through history that also changed regulation with the same magnitude as the Thalidomide disaster. If the thalidomide disaster did not happen, surely there would have been other drugs that could have negatively affected the public which the FDA would have regulated. One such event was the distribution of Elixir Sulfanilamide. It was a medicine that is used for streptococcal infections. It was safe in its inherent solid form however, has dangerous side effects when ingested in liquid form. It was distributed in solid form however, there was a demand for its liquid form which caused that population’s condition to worsen. If the Thalidomide disaster did not occur, this could surely be one of the events that would prompt the FDA to create regulations.