The changes were made in response to postmarketing reports that were received before June 2009.
这些变化主要是根据在2009年6月前收到的上市后报告而做出的。
Echoing that sentiment, Rosen pointed to mounting calls for the FDA to fund and oversee phase 4 postmarketing studies that actually have some teeth.
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。
Recently, there have been calls for the FDA to fund and oversee phase 4 postmarketing studies as a means of determining the safety of newly approved drugs.
最近，为了明确新批准药物的安全性，一直有呼声要求FDA投资并监测新药的上市后4期研究。
Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure.
在上市后监督后已报告的严重肝脏不良反应事件包括肝坏死、黄疸、伴有或不伴有黄疸的暴发性肝炎、肝衰竭。
Postmarketing surveillance reports include cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure.
上市后监测报告发现了重度肝脏不良反应病例，包括肝脏坏死、黄疸、暴发性肝炎伴或不伴黄疸、肝衰竭等。
The existing warning and precaution regarding severe skin reactions has been strengthened to reflect postmarketing reports of severe, potentially life-threatening, and fatal skin reactions.
现有关于严重皮肤反应的警告和注意事项已被突显，以反映严重、潜在致命性及致死性皮肤反应的上市后报告。
In the postmarketing period, additional cases of injection site reaction with features including induration, cellulitis, hematoma, abscess, sterile abscess, and necrosis, have been reported.
在该药上市后期间，已报道发生其他包括以硬结、蜂窝织炎、血肿、脓肿、无菌脓肿以及坏死为指征的注射部位反应事件。
This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-m...
需要就中药上市后临床再评价过程中需注意若干问题，如再评价的法规要求、评价依据、评价对象选择等做初步探讨。
This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-m...
需要就中药上市后临床再评价过程中需注意若干问题，如再评价的法规要求、评价依据、评价对象选择等做初步探讨。
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