Current Edition

Interim Report Shows FDA Meeting Goals for Efficient, Transparent Review of Biosimilars Applications

The Program for Enhanced Review Transparency and Communication for 351(k) biologics license applications (BLAs) of the US Food and Drug Administration (FDA), provided for in the Biosimilar User Fee Act (BsUFA), has been “successful” and has provided enhanced review transparency and communication to industry. Molly Fellin Spence at Clarivate evaluates the interim report that shows FDA meeting goals for efficient, transparent review of biosimilars applications.

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