viernes, 10 de mayo de 2013

Drug Information Update - FDA Hiring Initiative: Generic Drug User Fee Amendments of 2012 (GDUFA)

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law. GDUFA is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry.
Industry will now pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.
These additional resources will enable the FDA to reduce a current backlog of pending drug applications, cut the average time required to review them for safety, and increase risk-based inspections.
GDUFA will also enhance global supply chain safety by requiring generic drug facilities/sites worldwide to self-identify and meet FDA standards for safety, purity and effectiveness.
For information on Pharmacist positions at FDA in the Washington, DC Metro Area please visit: Pharmacist
For information on Medical Officer positions at FDA in the Washington, DC Metro Area please visit: Medical Officer
More information on the FDA Hiring Initiative: GDUFA of 2012 can be found at: GDUFA Hiring

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