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Re: DewDiligence post# 133231

Saturday, 12/17/2011 11:59:41 AM

Saturday, December 17, 2011 11:59:41 AM

Post# of 257262
I really dont know. What I posted came from a tweet of someone at BioWorld who was at the public hearing on FoB's/biosimilars/etc.

From BioWorld's story today
http://www.bioworld.com/content/washington-roundup-annual-biosimilar-fees-only-stopgap-industry-tells-fda

"Meanwhile, the agency is working on a guidance that will help implement the biosimilar path. Although the FDA had hoped to have the guidance out this year, Theresa Mullin, director of the office of planning and informatics, indicated at the meeting that the guidance wouldn't come out until the second quarter of 2014."

It's outrageous how slowly they're moving on this; they go from leading people to believe it was coming at the end of this year and now they push it back 2 1/2 years.

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