Margaret Hamburg, FDA Commissioner released an article commenting on the recent meningitis outbreak. On September 18, 2012 it was confirmed that a patient in Tennessee had meningitis. By September 27, there had been eight more additional patients with similar meningitis symptoms, but lab results were not showing a clear cause. Tennessee, the state hit hardest by this outbreak has been working to treat the victims affected by this outbreak. On October 3, Tennessee public health officials, in collaboration with the CDC and the North Carolina Department of Health and Human Services had identified a steroid solution compounded at the New England Compounding Center (NECC) as the likely source of the outbreak. Commissioner Hamburg shared that FDA is ensuring that the recall of NECC products is carried out. FDA is urging healthcare providers to follow up with patients who were administered any NECC injectable product shipped on or after May 21, 2012. Click here to read Hamburg’s article. We will be watching and observing future moves by FDA to address new regulatory actions in the area of compounding pharmacies.
Obstacles Facing Biosimilars
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