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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Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
Increasing number of product development meetings suggests that many complex generics remain in the development stages.
Generics industry and FDA also debated inspection policies in lieu of travel and safety restrictions mandated by the pandemic.