Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure.
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与这种情绪相呼应,Rosen指向不断高涨的呼声,FDA资助并监督具有真正意义的4期上市后研究。
Echoing that sentiment, Rosen pointed to mounting calls for the FDA to fund and oversee phase 4 postmarketing studies that actually have some teeth.