"The first five years of PDUFA
1, as we called it, were a startling, unqualified success.
(Nasdaq:KPTI) revealed on Thursday that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA
) action date for the New Drug Application (NDA) for selinexor for the treatment of relapsed refractory multiple myeloma.
The NDA will be subject to a standard review and will have a PDUFA
action date of 24 January 2015.
With the industry's support, PDUFA
was reauthorized in 1997 and again three years ago.
The two associations released a joint statement in which they credited PDUFA
with helping the regulatory agency to keep pace with the rapid increase in the number and complexity of innovative drugs and biologics requiring regulatory review.
The stated goals for this version of the PDUFA
include placing PDUFA
on a sound financial footing, enhancing pre-market review, and creating a modern post-market drug safety system that follows products across their full life cycle.
WASHINGTON -- The Prescription Drug User Fee Act (PDUFA
) has benefited not only the millions of Americans who rely on innovative drugs and biologics but also U.S.-based drug manufacturers as they compete around the world.
User fees for pre scription drug and biological products are currently authorized under the Prescription Drug User Fee Amendments of 2007 (PDUFA
At the meeting sponsored by FDA, outside groups voiced concerns about the agency's proposal for the PDUFA
program and made their case for how FDA should organize and spend requested funding, The Pink Sheet reports.
The company said it expects a complete response letter from the FDA on or before the PDUFA
While it remains possible that the FDA may elect to convene an AdCom, with less than two months remaining prior to the PDUFA
date Amarin is now assuming that an AdCom is unlikely.
M2 PHARMA-December 26, 2017-FDA Extends BioMarin PDUFA
Date for Pegvaliase Biologics License Application