Sedana Medical AB (publ), a pioneer medtech and pharmaceutical company, announces that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the evaluation of isoflurane via the Sedaconda ACD-S device for sedation of mechanically ventilated patients in the intensive care (ICU) setting.
Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need. The purpose is to get important new therapies to the patient earlier. Clinical programmes with Fast Track Designation may benefit from frequent communication with the FDA throughout the development and review process and may be eligible to Accelerated Approval and Priority Review if relevant criteria are met. Another possible benefit may be a Rolling Review, which means that completed sections of the New Drug Application (NDA) can be submitted for review by FDA, rather than waiting until every section of the NDA is completed.
