FDA says it will no longer require medical evaluations and signed waivers before consumers purchase a hearing aid, and it is considering a new OTC app...
Federal Register Notice: FDA makes available data extracted from adverse event reports from 2004 to the present for food (including food additives, co...
President-elect Donald Trumps reportedly considers a Silicon Valley venture capital manager to take the helm at FDA.
Federal Register Notice: FDA determines the regulatory review period for Mercks Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) for pa...
Bloomberg News reports that a recent FDA inspection at Suns plant in Halol, India, resulted in a 14-page FDA-483.
Medtronic and Fitbit partner on a mobile app to help Type 2 diabetes patients track glucose levels and physical activity.
FDA grants Voluntis 510(k) clearance for Insulia, a digital solution intended to support the effective management of Type 2 adult diabetes patients tr...
Kitov Pharmaceuticals Holdings completes FDA-required stability testing on nine pivotal batches of KIT-302, which the company says sets the stage for ...