Amendments to the 21st Century Cures Act: Changing the Regulation of Combination Products

Posted 14 April 2017 By Robert D. Cumming, Nancy W. Mathewson, Esq

placeholder+image This article summarizes regulatory changes impacting how premarket applications for combination products will be reviewed by FDA and procedures and reporting requirements for applicants and FDA as required by the 21st Century Cures Act.

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Categories: Biologics and biotechnology, Combination products, Drugs, Medical Devices, Features, US, FDA

Tags: 21st Century Cures Act, Combination Products, Primary Mode of Action, PMOA

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