条件下可批准(approvable letter) – 提供申请方听证机会 • 不可批准新药申请(not approvable letter) – 提供申请方听证机会 Squire, Sanders & Dempsey L.L.P.
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not approvable letter 不批准信
approvable letter
可核准的信
以上为机器翻译结果,长、整句建议使用 人工翻译 。
The FDA also gave Byetta an "approvable letter" for its use as a single-agent therapy.
FORBES: Magazine Article
An "approvable letter" is usually one of the final steps before the FDA approves a drug.
FORBES: FDA Gives Conditional Approval To Lilly's Xigris
However, a person who had spoken to people at Pfizer said the company had received an approvable letter.
FORBES: Pfizer Plays A Guessing Game
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