The Food and Drug Administration (FDA) human medical product user fee programs, covering prescription drugs (PDUFA), medical devices (MDUFA), ...
The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing ...
It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act. Leaders in both the branded and ...
On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team ...
> Eli Lilly ($LLY) by next year expects to be using four different continuous processing platforms for production of many of its new products. Story > The University ...
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The FDA has posted draft guidance to prepare for a GDUFA-driven surge in data on the generic drug supply chain. And it is a familiar scenario, with the FDA drawing heavily on the 2009 electronic drug ...
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