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Posts tagged ‘FDA Drugs’

The U.S. Food and Drug Administration (FDA) plans to launch a new office in 2015.  This new Office of Pharmaceutical Quality (OPQ) will be dedicated to ensuring that quality medicines are available to U.S. citizens.  According to the OPQ webpage, OPQ will create a uniform drug quality program across all domestic and foreign sites of […]

The Generic Drug User Fee Amendments (GDUFA) of 2012 grant the U.S. Food and Drug Administration (FDA) the authority to collect user fees from the generic drug industry to assist with the cost of regulation, from reviewing drug applications to inspecting facilities.  FDA uses a portion of the collected fees to fund the regulatory science […]

On August 27, 2014, the U.S. Food and Drug Administration (FDA) published “Controlled Correspondence Related to Generic Drug Development,” a draft guidance detailing what FDA considers to be a controlled correspondence and the proper way to submit a controlled correspondence. In a Generic Drug User Fee Amendments of 2012 (GDUFA) commitment letter, FDA agreed to […]

The Generic Drug User Fee Amendments (GDUFA) of 2012 give the U.S. Food and Drug Administration (FDA) authority to collect annual user fees from active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities.  The fees are due on October 1 of each year. FDA must receive the full payment within 20 days of the […]

Before August 2014, a total of only five companies had ever received warning letters from the U.S. Food and Drug Administration (FDA) regarding failure to pay generic drug user fees. On August 7, 2014, FDA added three additional companies to its list of non-compliers: Colgate, Explora Laboratories, and Korea United Pharm. The FDA warning letters […]

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