ANDA Approvals Jump 44%; FDA Works On Roadblocks As Review Times Drop
FDA's Office of Generic Drugs approved 380 abbreviated new drug applications in 2004, a 44% increase over the previous year
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FDA is taking another look at its citizen petition review process in an attempt to expedite decisions on generic drug applications, Center for Drug Evaluation & Research Acting Director Steven Galson told the Generic Pharmaceutical Association's annual meeting Feb. 25 in Boca Raton, Fla
The Division of Bioequivalence in FDA's Office of Generic Drugs has begun conducting dissolution tests earlier in the ANDA review process to speed approvals
The redrafting process on FDA's drug substance guidance is fanning debate over the role of the marketing application in the evolution of a more science- and risk-based quality regulatory paradigm