FDA's First Major Action On Establishing User Fees For Biosimilar Applications Under PHSA 351(K).
Mondaq Business Briefing › Nbr. 2011, January 2011
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Food and Drug Administration
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FDA's First Major Action On Establishing User Fees For Biosimilar Applications Under PHSA 351(K).
On 9 May 2011, the Food and Drug Administration (FDA) issued a request for comments on the agency's proposed options for a user fee program for biosimilar and interchangeable biological applications for fiscal years 2013-17, which is required by the Biologics Price Competition and Innovation Act of 2009...
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