PDUFA V and Investor Communications
This article was originally published in RPM Report
Executive Summary
The Prescription Drug User Fee Act reauthorization made a number of important changes to the new drug review process and programs for stakeholder engagement with FDA. It also created a number of new investor communication challenges for sponsors.
You may also be interested in...
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?
Breakthrough Math: Alexion Gains $400 Million on Asfotase Breakthrough Designation
There’s a lively debate underway as to what FDA’s new breakthrough designation means for a sponsor and for the likelihood of a product’s regulatory and commercial success. Alexion’s post-Memorial Day bump dramatizes the positive impact on Wall Street.
GAIN Begins (Part 1): FDA Completes Turnaround On Antibiotic R&D
In less than two years, FDA has moved from requiring unrealistic approval standards for antibiotics to exploring innovative ways to shorten the pathway for the most-needed drugs. And, surprise: Congress is on board too. After 15 years, there is finally real momentum on antibiotic drug policy. But is it all enough to get companies back in the game?