FDA warns a clinical trial site in Ukraine that it failed to properly maintain required records.
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...