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Biosimilar User Fee Meeting Schedule Allows FDA Data “Pre-Review”

 
• By Derrick Gingery

Agency officials are willing to meet with sponsors during their development programs to look at data and provide advice in part to ensure they remain on track, but also to promote a high first-cycle approval rate.

Biosimilar sponsors can expect FDA to actively participate in development programs long before a marketing application is filed, in part to help sponsors avoid costly and time-consuming missteps.

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