Complex Generics: US FDA, Sponsors View Roadblocks Very Differently
Executive Summary
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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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.
US FDA’s Drug Shortage Program On ‘Site Engagement’ To Be Nixed In GDUFA III
Generics industry and FDA also debated inspection policies in lieu of travel and safety restrictions mandated by the pandemic.