Biosimilar User Fee Negotiations Won't Start Until 2016
Mid-December kick-off meeting puts emerging user fee program on much later track than others.
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Agency staff efforts dedicated to 351(k) reviews increased more than 10-fold in fiscal year 2015, Eastern Research Group says.
As user fee negotiations begin, FDA has far more sponsors in product development phase and far fewer marketing applications than anticipated.
Workload is not what was expected when BsUFA was designed, FDA says.