Biosimilar User Fees: Industry, FDA Tussle On Ramp-Up Speed For Program
This article was originally published in The Pink Sheet Daily
Industry says performance goals should not be phased-in, but FDA says it does not have enough money to be full-strength at launch.
You may also be interested in...
BsUFA agreement negotiated between the agency and industry provides five different types of meetings during the pre-IND and product development stage. FDA will issue a draft guidance on the different types of biosimilar meeting opportunities by 2014.
Biosimilar INDs could be placed on “financial hold” if sponsors fail to timely pay product development fees under FDA’s inaugural biosimilar user fee deal with industry.
FDA looking at different ways and development milestones to charge the pre-marketing application fee.