FDA Policy/General

Medical Product Recalls Drop 10% in 2016

Just-released FDA enforcement statistics shows that recalls in FY 2016 fell 10% compared with recalls tracked in 2015. There were 8,305 product recalls in 2016, almost 900 fewer than the 9,178 recall actions in 2015. FDA Webview reported 2/14 that agency Warning Letters also fell substantially last year — dropping 15% compared with such letters issued in FY 2015, according to the enforcement statistics.

With recalls, CDER-regulated product recalls slipped 15% in 2016. The enforcement statistics show that 1,550 recalls were recorded at the drug Center last year, compared with 1,822 recorded in 2015. Medical device recalls were practically unchanged in 2016, with 2,898 recalls recorded compared with 2,850 the previous year. For biologics, recalls in 2016 dropped 20%, from 973 in 2015 to 781 in 2016.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome