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FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit

Executive Summary

Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.

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A firm will take ownership of US ANDAs from manufacturers unwilling to pay program fees or withdraw the approved generic drug application; is it a novel concept allowing future marketing options or simply fee avoidance?

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