FDA announces a 7/12-13 CDRH Patient Engagement Advisory Committee meeting that will discuss and make recommendations on augmented reality and virtual...
FDA warns Fresno, CA-based Generitech Corp. about multiple repeat violations in its production of finished drugs.
Federal Register notice: FDA determines that Clinigens Otect (dexrazoxane hydrochloride) for injection was not withdrawn due to safety or effectivenes...
FDA warns New Paltz-NY headquartered Ultra Seal Corp. about CGMP violations at its headquarters and two other drug manufacturing facilities in the sta...
FDA warns Clearfield, UT-based Yusef Manufacturing Laboratories about multiple repeated CGMP violations in its production of finished drugs.
Veru Inc. announces positive efficacy and safety results from an interim analysis of a Phase 3 Covid-19 clinical trial evaluating oral sabizabulin 9 m...
FDA publishes two guidances giving submitters using the 510(k) Safety and Performance Based Pathway for two specific products an option to use perform...
Attorney Jeffrey Shapiro says companies should be careful when calculating for FDA the risk of a medical device malfunction.