Some 30 House and Senate members ask CEOs of seven manufacturers of naloxone to seek OTC status for their drug.
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Federal Register notice: FDA determines that Clinigens Otect (dexrazoxane hydrochloride) for injection was not withdrawn due to safety or effectivenes...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...