RegDesk Blog

Priority Review

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 includes standard review and priority review. Here are some key points: 1. For priority...

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Do your labels comply with the E.U.’s MDR?

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 MDR has laid out requirements that further obfuscate the labeling operations of medical device...

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Fast Track Designation

Fast track designation was introduced to expedite the progress and review of new drugs designed to treat serious illnesses or fill an unmet medical need.  This designation’s primary intent is to get these important, possibly life-altering drugs, to the patient faster. According to the FDA, “filing an unmet medical need...

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