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Home » Expert Offers Tips to Achieve First Cycle ANDA Approval
Expert Offers Tips to Achieve First Cycle ANDA Approval
A first cycle approval of a generic drug would ensure quick access in the market and eliminate the need for additional communications with the FDA. However, this may not always be possible, as GDUFA I does not provide for adequate communication between industry and the agency during the presubmission and ANDA review stages, Aloka Srinivasan, a principal consultant at PAREXEL International said in a recent FDAnews webinar.