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Report: FDA hearing to discuss biosimilar regulations

9/21/2010

WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.


 


The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.


 


 


According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”


 


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