FDA proposes new BsUFA IV commitment letter to streamline biosimilar reviews
The U.S. Food and Drug Administration released a draft commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, highlighting several departures from the existing biosimilar review framework.
The agency says the proposed changes are aimed at speeding up biosimilar application reviews and boosting overall regulatory efficiency.
A CBER expert also reminded sponsors that early interaction with the FDA’s Office of Therapeutic Products, careful preparation to avoid technical errors, and keeping the regulatory project manager informed are key to successful biologics license applications.
This writeup was produced by pharmadog from original reporting by raps.
Original headline: “BsUFA commitment letter outlines changes to FDA’s biosimilar review program”
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