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< アンチ・エージングセミナー | メイン | HGF-STATへのEditorial >

FDAの改革

ryu-chan / 2008.07.13 15:59 / 推薦数 : 0

日経バイオテクノロジーによると、FDA（アメリカ食品医薬品局）は、医薬品の認可の通知方法を変えるとのことです。

新たなルールでは、今まで、「承認可能（approvable）」または「承認不可（not approvable）」通知を出していたのですが、今後は審査終了時に「complete response」通知を発行、申請に対する判断を伝えるそうです。

今後使用される「complete response」レターは、製薬会社に、審査期間が終了したこと、申請は1つ以上の理由から現段階では許可できないことを知らせ、不足している点の全てについて記述し、可能であれば承認に向けて何を行うべきかについて概説するとのことです。

このことによって、何が足りないかが分かれば、再試験で認められやすくなるので、多少は医薬品が通りやすくなりそうですね。

ＨＧＦ（コラテジェン）のアメリカでのフェーズＩＩＩに向けて良いニュースですね。

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