Senate Appropriators Pay Attention To Generics … After Food Issues
This article was originally published in The Pink Sheet Daily
Executive Summary
Commissioner Margaret Hamburg questioned about generic labeling rule and ANDA review times.
You may also be interested in...
Life After White Oak: Hamburg’s Predecessors Offer Glimpse At Where Pharma Might See Her Again
In interviews with “The Pink Sheet,” the last half-dozen FDA commissioners discuss crafting policy on Capitol Hill, building start-up biotechs, consulting and serving on industry boards.
CDER, CBER Not Seeing Hiring Slowdown Despite US FDA Warnings
FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.
Parallel Scientific Advice: Is The EMA User Fee Impacting Interest?
EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.