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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

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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.

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