Regulatory Focus™ > News Articles > FDA Seeks Input on Biosimilars Application

FDA Seeks Input on Biosimilars Application

Posted 12 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is calling for public input on its biosimilars user fee cover sheet, including ways that its quality, utility and clarity might be improved.

The request is one of the more practical aspects of the implementation of the Biologics Price Competition and Innovation Act of 2009, in which FDA was granted the authority to regulate biosimilar products.

The user fee program is scheduled to start in 2013 and run until 2017, at which time it will be up for renewal by Congress.

FDA anticipates that each biosimilar user fee form will take approximately 30 minutes to complete.


Read more:

Federal Register - Agency Information Collection Activities; Proposals, Submissions, and Approvals: Biosimilars User Fee Cover Sheet


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