Industry avoided application supplement fees by using CBE submissions instead, forcing FDA to change its estimates and sending generic drug user fees higher.
A change in the type of generic drug application sponsors submit to reflect moderate manufacturing process or other changes may have significantly affected GDUFA user fees.
Much of the increase in the fiscal year 2014 generic drug user fees was attributed to a rebalancing of the...
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
