The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
Category Archives: Drug Safety Information Podcasts
FDA advises testing for Zika virus in all donated blood and blood components in the US
As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
FDA advises testing for Zika virus in all donated blood and blood components in the US
As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
FDA Statement on Medical Device User Fee Agreement (MDUFA)
The FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of a medical device user fee program. Under the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in October 2017. This funding would provide critical resources to the FDA medical device review program. Details of the draft agreement will be published for public comment in the coming weeks, and the final recommendations are scheduled to be delivered to Congress in January 2017.
FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury
The U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.
FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery.
FDA updates draft guidance on premarket safety notifications for dietary supplement industry
The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.
FDA issues draft updated recommendations on submitting a new 510(k) for device modifications
The U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
Kratom seized in California by US Marshals Service
The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000.
Statement from Peter Marks, M.D., Ph.D., Director, FDA’s Center for Biologics Evaluation and Research
The FDA is tasked with taking important steps to respond to the emerging Zika virus outbreak. One of the agency’s key public health responsibilities is to help ensure the safety of the nation’s blood supply.