FDA denies a Hyman, Phelps & McNamara petition seeking permission to submit an ANDA for generic Imodium with two different strengths than the referenc...
CDRH releases reports on its commitment to medical device innovation and safety.
Boston Scientific recalls its embolic agent Obsidio Embolic after an investigation finds that its use with the aliquot technique for lower gastrointes...
Sen. Bill Cassidy says FDA needs to explain why it ignored Congress and expanded its oversight over clinical decision support software.
Fresenius Kabi USA recalls its Ivenix Infusion Systems pump software due to a necessary software update.
FDA warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved uses, adulterating and misbranding the unit.
FDA warns the Telangana, India-based Natco Pharma manufacturing facility about CGMP violations in its production of finished drugs.
CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinical trials that are designed to improve the quality...
