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Amendments to the 21st Century Cures Act: Changing the Regulation of Combination Products By Robert D. Cumming, Nancy W. Mathewson, Esq - Published 14 April 2017

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.

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

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