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The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of a combination drug-device product. Read More
Biosimilars with “skinny labeling” saved Medicare $1.5 billion over 5 years, equivalent to almost 5 percent of what the federal system spent on five pricey biologics, according to a new report in JAMA Network. Read More
The FDA is investigating reports that the osteoporosis medicine Prolia (denosumab) may cause dangerously low calcium levels in the blood of patients with advanced kidney disease, particularly those on dialysis. Read More
A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
The FDA is not extending its enforcement discretion policy for Investigational New Drug (IND) requirements governing the use of fecal microbiota for transplantation (FMT) obtained from stool banks for treatment of C. difficile infection that is not responding to standard therapy, the agency said in a final guidance released yesterday. Read More