Monday, June 3, 2013
FDA, PhRMA and BIO spent months crafting a
new, "enhanced" review process for new molecular entities as part of
PDUFA V negotiations, and the trade associations don't want to wait years to
find out if it is performing as intended.
To assess progress, inform
efforts to fine tune the process, and provide grist for the PDUFA VI
negotiations in 2016, PhRMA and BIO have launched a PDUFA V tracking database.
The goal is to produce detailed data in real time about sponsor-FDA
interactions from pre-NDA/BLA meetings through final regulatory actions.