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Complex Generics: Pre-Competitive Research Collaborations To Get US FDA Funding Boost

Executive Summary

Center for Research on Complex Generics will be similar to the Critical Path Institute; training sessions for industry could begin in January.

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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.

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.

FDA And Industry Set Out GDUFA III Priorities

Both first-cycle approvals and priority assessment improvements have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.

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