Drug-coating heart Stents

http://online.wsj.com/article/SB120654300392165477.html?mod=health_home_stories

FDAがDrug-coating heart Stents（説明はEBSにかかれているBlogに丁寧に説明されていました。1)と2)を併読しましょう）の承認条件に長期間にわたる安全性のテスト結果の提示を求めている話。

The Food and Drug Administration on Wednesday issued draft guidelines for makers of drug-coated heart stents that formalize the view that longer studies are needed before devices are submitted for approval, in order to better scan for potential safety problems.

現在承認済みのデータは9ヶ月であるが、これからは（12ヶ月間のデータと）2年のデータがいる。

The agency, which held a two-day meeting on the safety issue in December 2006, said in Wednesday's guidance documents that it thinks longer-term data is needed.

"FDA currently believes that a 12-month primary endpoint, with a substantial proportion of patients having 2-year data at the time of marketing application submission, is critical to assess the potential for important adverse events" that may occur after nine months, the agency said.

新しい技術が寄与する健康と経済性と安全性の両立の確保は永遠のテーマであるが、数字で議論しようということ。