J&J development unit slapped with FDA warning letter

Johnson & Johnson's drug development unit has been slapped with a warning letter saying that it "did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations." A spokesman for J&J said that the letter related to its clinical development work on the antibiotic ceftobiprole, which the agency refused to approve last fall as it probed researchers' clinical trial work. The agency found several "objectionable conditions," including a failure to properly monitor two studies and make sure that researchers followed the study plan. The company also didn't make sure researchers were properly experienced and trained. Report