Shares in SteadyMed (NSDQ:STDY) fell last month after the FDA decided it would not review the new drug application for the company’s drug-device combination product, Trevyent.
SteadyMed received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. The company submitted its application to the FDA in June, but the federal watchdog has requested more information on certain device specifications and performance testing, as well as additional design verification and validation testing.
Get the full story at our sister site, Drug Delivery Business News.
The post SteadyMed requests meeting with FDA over rejected application for drug-device combo appeared first on MassDevice.
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