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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