Drugs

CDER Deputy Throckmorton Retiring in January

CDER deputy director for regulatory programs Doug Throckmorton is retiring in early January after 27 years at the agency. While there has been speculation that some FDA employees may be seeking the exit door based on anticipated disruptions from the incoming Trump Administration (see earlier story), CDER director Patrizia Cavazzoni said in an email to staff that Throckmorton made his retirement plans known to her back in September before the election.

Throckmorton joined CDER in 1997 as a medical officer in the Division of Cardiac and Renal Drug Products. In 2002, he was promoted to division director in 2002. He became acting deputy center director in 2004, which was made permanent in 2005.

“During his service as deputy Center director, Doug has overseen many critical and complex areas in the CDER portfolio, including the regulation of controlled substances, drug shortages, counterterrorism and emergency coordination, combination product regulation, and the impact of pharmaceuticals in the environment,” Cavazzoni says.

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