Executives from Aquestive Therapeutics (NASDAQ:AQST) said the U.S. Food and Drug Administration has issued a complete response letter (CRL) for the company’s New Drug Application for Anaphylm, an ...
U.S. and EU regulators require human factors and usability testing to bring a medical device to market. Virginia Lang, PhD, president and chief scientist at HirLan Inc., an engineering consultancy ...
“Anyone doing design, development, or postmarket surveillance for a medical product that humans use should be considering human factors and usability,” Shannon Hoste, chief scientific officer at ...