The House Appropriations Committee posts a draft fiscal year (FY) 2020 spending bill that would provide $5.85 billion for FDA $167 million more than ...
An Exeed blog post says a new FDA regulatory approach can help the medical device industry avoid repeat violations by providing agency consultation he...
FDA warns Indias Centurion Laboratories about CGMP violations in its production of finished pharmaceuticals.
FDA warns Zeller Power Products about Quality System and other violations in its manufacturing of an automated external defibrillator replacement batt...
CDER Office of Surveillance and Epidemiology researchers say more work is needed to address bias introduced by stimulated adverse event reporting on s...
FDA warns Orchid Orthopedic Solutions about Quality System violations in its work applying coatings to some orthopedic implants.
Stakeholders comment after an FDA public hearing on enhancing incorporation of patients perspectives in clinical trials.
FDA clears a Body Vision Medical 510(k) for the LungVision 2.0 System.