Food facilities are not expected to report to FDA incidences of contamination unless they suspect that the contaminated food has entered distribution. Hence most food contamination found during manufacture are not reported to the FDA. Recent outbreak of listeria contamination at Blue Bells plants exposed this gap between expectation from and the reality of enforcement … Read more
This week FDA posted a review of its drug approval process based on the principle of benefit-risk-assessment that shows it gives special consideration to new molecular entities (NMEs) intended for diseases with few or no treatment options with regards to market approval decisions. Over the last decade, FDA emphasized the value of putting the safety … Read more
Duodenoscopes are widely used reprocessed devices for ERCP. Improper cleaning and disinfection of duodenoscopes is the cause of several incidences of infections including MRSA episodes annually. At a recent FDA Advisory Committee meeting, the risk and safety issues related to these devices were discussed. The gastroenterology and urology devices advisory panel of FDA observed that … Read more
This week FDA’s Arthritis Advisory Committee recommended approval of Remsima, a biosimilar product to Remicade. Remsima was developed by South Korea’s Celltrion. Remicade is one of Janssen’s biggest products with annual revenue of about $7 billion. There are several firsts in this decision. This is the first biosimilar to a monoclonal antibody reviewed by an FDA advisory … Read more
