GDUFA II: FDA, Industry Reach Tentative 'Alignment' On ANDA Review Issues
This article was originally published in The Pink Sheet Daily
Negotiations to renew user fee program continue as finance issues remain unresolved.
You may also be interested in...
FDA and industry say they have reached tentative agreement, but finance subgroup says more discussion needed.
Finance subgroup talks about new structure for generic drug user fee program that could mean bigger firms would pay more.
Final GDUFA I application fees decrease amid expected boost in submissions, while facility fees will increase for the fourth time in five years.