Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement
Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.
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Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.
Six supplement categories based on submission content will be created with review goals between three and 10 months.
New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.