Drugs

Acting Chief Scientist Borio on Detail at White House

FDA acting chief scientist Luciana Borio has accepted a one-year detail with the National Security Council to assist with medical and biodefense preparedness. CDER Office of Medical Policy acting director Denise Hinton is being reassigned to the permanent position of deputy chief scientist, and she has agreed to serve as acting chief scientist until the search has been completed to fill the position permanently.

Hinton joined FDA in 2002 in CDER’s Division of Cardiovascular and Renal Products. From 2010 until 2013, she served as CDER Office of Medical Policy Initiatives director. In 2013, she was appointed Office of Medical Policy deputy director. Prior to FDA, she was an officer in the U.S. Air Force.

Hinton has a nursing degree from Florida State University, and a master of science from Boston University.

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