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FDA’s First “Breakthrough” Approval Coming; Won’t Break Speed Records

This article was originally published in RPM Report

Executive Summary

Genentech’s oncologic obinutuzumab is expected to be one of the first Breakthrough therapies approvals under PDUFA V. The data look game-changing for chronic lymphocytic leukemia patients. But will it result in a faster FDA review? Under the agency’s new review Program, probably not.

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FDA’s First “Program” Reviews: Fast Approvals, But Still Some Surprises

The Food & Drug Administration is approving the first products under the new PDUVA V review process. The Program, as it is known, gives FDA an extra two months with an application in exchange for additional meetings for sponsors. It’s designed to help reduce the number of late-cycle “surprises.” There have been a few hiccups, but so far, it appears to be doing just that.

FDA’s “Breakthrough” Exceeds Expectations; Will It Break The Bank?

Drug sponsors are eager to use FDA’s new “breakthrough” therapy development pathway, and the agency is granting designations at a much faster rate than originally expected. But the “all hands on deck” approach required by FDA officials for breakthrough is resource-intensive at a time when the budget sequestration is preventing the agency from accessing all its available user fee funding. Is the popular program at risk?

Time for Transparency: PDUFA V’s Big “Experiment”

Industry came to the PDUFA V negotiating table with one big agenda item: improved communication with FDA officials about a product under review. They succeeded, but it came with a price: an extra two months for FDA to review an application. While it may seem like things just went back to 2002, both industry and the agency say it could actually lead to faster approvals.

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