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And the principle that we came up with is to devote a certain percentage of the reviewing resources to those products that have, or are having, the greatest impact on public health, either positive or negative, simply by virtue of share of market. The other aspect Zeller said the FDA is considering is fairness, giving priority to companies that submitted applications on time, regardless of that companys size or market share
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Customers whose applications or amendments to existing applications are denied in whole or in part may appeal to the manager, Product Classification (see 608.8.0)
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