Fda Vs Ema Case Study

Satisfactory Essays
The pemetrexed 2nd line accelerated approval by FDA versus approval by EMEA based on PFS and the Avastin FDA 1st line indication in combination with carbo-cisplatin versus the EMEA indication in combination with broader platinum based chemo based on PFS in the AVAiL trial illustrate the different attitudes of FDA and EMA to use of PFS for approvals in NSCLC. Another example of the difference in Agency approaches to the use of PFS is provided by the case of Avastin in combination with paclitaxel for breast
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