US FDA Preparing For Potential Bolus Of Complex Generic Applications
Increasing number of product development meetings suggests that many complex generics remain in the development stages.
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ANDA user fee goals likely would have to be reconfigured to account for business days and still maintain the intended length of time.
As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.
Center for Research on Complex Generics will be similar to the Critical Path Institute; training sessions for industry could begin in January.