PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing
Executive Summary
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
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US 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.
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.
Congress Already Preparing For User Fee Bills
Multiple congressional offices attended a briefing on GDUFA III with FDA and industry officials, suggesting plans for the must-pass bill already are in the works.