FDA warns CSL Behring that a direct-to-consumer TV spot for its Hizentra overstates the drugs effectiveness and minimizes its risks.
FDA warns Bellevue, WA-based SeniorLife.AI about multiple violations in its illegal marketing of an artificial intelligence-based device intended to s...
FDA issues an early alert about a Medline recall for specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Catheters based on an earl...
FDA warns Indias Somerset Therapeutics about CGMP and Field Alert Reporting violations in its production of finished drugs.
A Center for Innovation in Regulatory Science briefing paper stresses Chinas faster drug approvals and the need for sponsors to make coordinated submi...
FDA releases 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it unveiled a major pus...
FDA posts a draft guidance entitled Erosive Esophagitis: Developing Drugs for Treatment that outlines recommendations for developing such products.
Dexcom recalls (Class 1 device correction) its Dexcom G7 App and Dexcom ONE+ App which contain a software design error.
