GMP: GDUFA: New Fee Act for the Generic Drugs and APIs Industry adopted by the Congress
26.07.2012
The US Congress passed the so-called \"Generic Drug User Fee Act\" (GDUFA). This act allows the FDA to charge Generic Drug companies who submit a marketing authorisation application for generics (Abbreviated New Drug Application; ANDA), a variation application or a Drug Master File.
The source of the news: http://www.gmp-compliance.org/eca_news_3218_7343,7400,7388.html
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