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Each drug marketed in the United States must go through a review process that is facilitated by the FDA. The Prescription Drug User Act (PDUFA) better facilitates faster drug review times as a two-tiered system, which...
Although the European Medical Devices Regulation (MDR) will not go into full effect until 2022, if your medical device company does business in the European Union, you may need to modify your labeling before then. The...