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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. Read More
Teva Pharmaceuticals scored FDA approval for its generic of the blockbuster erectile dysfunction drug Viagra, but it won’t be commercially available anytime soon. Read More
The FDA has made final decisions on roughly two-thirds of the GDUFA backlog of long-standing applications since the program’s fiscal 2013 inception, and met its final hiring goals 11 months ahead of schedule, the agency says in its fiscal 2015 GDUFA report to Congress. Read More
The FDA has given the green light to the chronic lymphocytic leukemia treatment Venclexta, which will be marketed by AbbVie and Roche’s Genentech unit. Read More