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US Capitol Capsule: Don't Make Assumptions On Biosimilars Actions, FDA Official Warns

 
• By Donna Young

While FDA action dates may have come and gone on some biosimilar applications, known as 351(k)s, it would be wrong to make an assumption regulators had issued a complete response letter (CRL) due to the lack of biosimilarity, warned Leah Christl, associate director for therapeutic biologics.

While FDA action dates may have come and gone on some biosimilar applications, known as 351(k)s, it would be wrong to make an assumption regulators had issued a complete response letter (CRL) due to the lack of biosimilarity, warned Leah Christl, associate director for therapeutic biologics.

"As a general matter, for any application, there's a number of things that could create a bump in the road,"...

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