A CDER study of factors that may predict the likelihood of generic drug marketing applications

FDA

28 October 2020 - The investigators compiled proprietary data related to abbreviated new drug applications and other internal or public information maintained by FDA, as well as published information on drug sales, to learn whether a drug’s characteristics, or factors related to its regulatory history or market sales were predictive of an abbreviated new drug application submission.

All abbreviated new drug application submissions were compiled for 400 brand name drugs for which it had become lawful to submit an abbreviated new drug application between 2011 and 2017.

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Michael Wonder

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Michael Wonder