accelerated approval programの例文

例文

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1. It was approved in the US in 2011 under the FDA's accelerated approval program.
2. Meantime, Roberts said it is in talks with the Food and Drug Administration to gain approval for its cardiovascular drug, ProAmatine, under the FDA's accelerated approval program.
3. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as phase 4 confirmatory trials.
4. On December 3, 2014, the drug was approved for use in the United States to treat Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia under the FDA's accelerated approval program; marketing authorization depended on the outcome of clinical trials that were ongoing at the time of approval.
5. "' Blinatumomab "'( trade name "'Blincyto "', previously known as "'AMG103 "'and MT103 ) is a biopharmaceutical drug used as a accelerated approval program; marketing authorization depended on the outcome of clinical trials that were ongoing at the time of approval.