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Generic User Fee Negotiations: Should Different Kinds Of ANDAs Pay More?

Executive Summary

The generic industry largely rejects one of the theoretical structures floated by FDA for an ANDA user fee program: paying more for reviews of complex drugs. But the concept does have support from many consumer advocates and at least one member of the Generic Pharmaceutical Association's board of directors, suggesting that the approach might continue to guide regulatory thinking even if it is not part of the final deal between industry and the agency.

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