FDA cautions Aspen Institute that it is illegally marketing cellular and exosome products to treat diseases and conditions in humans.
Epstein, Becker & Green attorney Bradley Thompson says there are differences between counties in the numbers of medical device inspections.
The Senate Health, Education, Labor & Pensions Committee delays a 1/5-scheduled confirmation vote on FDA commissioner nominee Robert Califf until 1/15...
Attorneys Jeffrey Gibbs and Gail Javitt say FDA contributed to the shortage of Covid-19 tests and call for a thorough, objective review of FDAs perfor...
FDA calls on isotretinoin manufacturers to propose a workable solution to issues with the iPLEDGE REMS Web site and telephone call center so treatment...
FDA warns Kirkland, WA-based Amcyte Pharma it is illegally selling Nasitrol, an unapproved and misbranded drug, as a Covid-19 cure.
FDA grants AbbVie a breakthrough therapy designation for telisotuzumab vedotin and its use in treating certain patients with advanced/metastatic epide...
FDA says the Cybersecurity and Infrastructure Security Agency has identified vulnerabilities in the Fresenius Kabi Agilia Connect Infusion System.