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krp76 replied to the topic Thalidomide's Impact on Regulation and the FDA in the forum Introduction to Project Management 8 years, 7 months ago
I agree with what everyone else has said, that the thalidomide crisis played a pivotal role in shaping the regulatory authority of the FDA and creating more awareness to remain vigilant. Without the thalidomide crisis the FDA may have had a more lax environment in approving drugs that were already approved in other international markets, unless another similar tragedy occurred to shine light on the importance of regulating internationally approved phamarceuticals/medical devices. This goes back to the point that Dr. Simon’s mentioned in the lectures as well that the FDA is known to be the most strict in regulation compared to similar international agencies. This crisis helped shape that aspect of the FDA as they still have strict guidelines for outside products even if they are already approved and used in other markets.