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

This article was originally published in Scrip

Executive Summary

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.

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