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The pragmatic “trial within a registry” design may provide a mechanism for conducting low cost, high efficiency trials in a heretofore-understudied patient population.
Terumo Signs Consent Decree with the FDA (Press Release)
During an inspection last year at Terumo Cardiovascular Systems Ann Arbor, Mich., plant, FDA officials found numerous violations to good manufacturing practice and medical device reporting requirements. On March 17, Terumo executive officers signed a consent decree of permanent injunction and under its terms, Terumo will pay almost $35 million in profits from past sales to the federal government.
Myocardial Reperfusion Injury: Etiology, Mechanisms, and Therapies
Although single therapies have shown some promise, the complexity of the response to reperfusion has made dramatic improvement elusive. Effective treatment will most likely require multifaceted antagonism of the numerous pathological cascades initiated by reperfusion.