Complex Generics: US FDA, Sponsors View Roadblocks Very Differently
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.
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FDA Seeks New Generics Chief As Choe Moves On
The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.
GDUFA III Talks Completed
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
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.