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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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posted from
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2012.05.10 00:17
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2012.05.10 03:32
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posted from
Regały magazynowe
2012.05.11 08:08
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Read was interesting, stay in touch…
[...]please visit the sites we follow, including this one, as it represents our picks from the web[....
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Best Battery Chargers
2012.05.12 23:14
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世迷い独り言 Doctors Blog 医師が発信するブログサイト
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2012.05.18 21:13
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2012.05.22 12:47
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世迷い独り言 Doctors Blog 医師が発信するブログサイト
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posted from
quantitative filter paper
2012.05.25 05:28
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Websites you should visit
[...]below you’ll find the link to some sites that we think you should visit[...]…
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posted from
free articles
2012.05.25 10:25
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Read was interesting, stay in touch…
[...]please visit the sites we follow, including this one, as it represents our picks from the web[....
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posted from
treasure island san francisco
2012.05.28 13:42
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Recommeneded websites
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posted from
bestseller
2012.05.28 16:47
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私はあなたについてのこの記事を書くに入れてすべての努力に感謝 ?????? Doctors Blog ????????????? . 私は私のクライアントのいくつかはそれは面白いかもしれないと思うように私は私のウェブサイトにあなたのブログにバックリンクバックを投稿します。
written by
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/ 2012.03.22 20:09
?????? Doctors Blog ????????????? 私が探していたものです。情報をありがとうございました。
written by
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/ 2012.03.24 05:40
私はあなたが本当に私の主題を理解する助けと言いたい ?????? Doctors Blog ?????????????
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/ 2012.03.24 07:48
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