“First Generics” Will Get Expedited ANDA Reviews Under New FDA Policy
Executive Summary
FDA's "First Generics" policy sets a priority review goal of six months for ANDAs for which there is no marketed generic equivalent
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GIVE Generics A Break: FDA Review Plan Draws Grumbles From Industry
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GIVE Generics A Break: FDA Review Plan Draws Grumbles From Industry
FDA's announcement about its new review procedures for generic drugs may well be tailored to have more impact on congressional appropriations committees than on the ANDAs themselves