Salix Pharmaceuticals Ltd and its partner Norgine BV on Friday jointly announced the receipt of notice from the US Food and Drug Administration (FDA) for the extended PDUFA
action date for its review of the New Drug Application for PLENVU (NER1006) for bowel cleaning.
The February 28, 2018 PDUFA
date and the advisory committee plans are consistent with our previously disclosed expectations.
requires the FDA to respond to drug applications
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.
requires congressional reauthorization every 5 years.
Although that argument carried the day in 1996, another showdown seems inevitable this year, since PDUFA
will expire in September.
The FDA has indicated that the extension of the PDUFA
date is needed to allow additional time for review of the application.
The company's New Drug Application for plazomicin is currently under regulatory review, and the change to VAI status provides a clear regulatory path for approval for plazomicin out of the McPherson facility based on plazomicin's PDUFA
date of June 25, 2018.
is US legislation which was initially enacted in 1992 and renewed in 1997, 2002, 2007 and 2012.
Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president for scientific and regulatory affairs David Wheadon offered that assessment in written testimony earlier this month before a congressional committee meeting on the reauthorization of PDUFA
In case you don't know, the PDUFA
provides funds paid by pharmaceutical companies to support the review of drugs by FDA.
Today, as implementation of PDUFA
V officially commences, PhRMA and BIO stand together to usher in an exciting new era in regulatory science - a period that holds great promise for bringing new, innovative medicines to patients in a timely manner.