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Re: DewDiligence post# 196514

Tuesday, 11/03/2015 12:06:31 PM

Tuesday, November 03, 2015 12:06:31 PM

Post# of 257262
US FoB factoids—FDA has acknowledged the existence of 57 programs using the 351(K) pathway pertaining to 16 reference products:

http://www.pharmexec.com/fda-looks-limit-clinical-trials-biosimilar-rd-0

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