Biosimilar User Fee Agreement Includes “Financial Hold” On Development Programs For Failure To Pay
This article was originally published in The Pink Sheet Daily
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.
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Staggering the payment of fees during product development rather than paying all on application submission could enhance FDA's ability to hold timely meetings with sponsors, Avalere Senior VP Woollett says.
A Federal Register notice outlines the new user fee amounts and suggests that President Obama’s budget projections anticipated as many as 10 marketing applications, but the mix of INDs and full applications is unknown.
An Energy and Commerce subcommittee will discuss the FDA and industry agreement on prescription drug user fees with FDA Commissioner Margaret Hamburg Feb. 1. Drug shortages will be part of the deliberations Feb. 7 when CDER Director Janet Woodcock goes before the panel to make the case for user fees on generic drugs and biosimilars.