Drugs

CDER Hires Pfizer Exec as Operations Chief

CDER has hired former Pfizer senior vice president Patrizia Cavazzoni as deputy director for operations, replacing Richard Moscicki who joined Pharmaceutical Research and Manufacturers of America late last year as the group’s chief medical officer (see earlier story). Cavazzoni joins Bob Temple, deputy director for clinical science, and Doug Throckmorton, deputy director for regulatory programs, in Center director Janet Woodcock’s office.

Cavazzoni has more than 15 years of pharmaceutical industry experience, with expertise in global clinical development, clinical trials, product safety, and regulatory affairs. Previously at Pfizer, she was head of worldwide safety and led safety reporting and surveillance activities, risk management, and global labeling strategy and operations. Prior to Pfizer, Cavazzoni served as vice president and head of global pharmacovigilance and epidemiology at Sanofi-Aventis. She also held leadership roles at Eli-Lilly, where she directed safety surveillance and pharmacoepidemiology operations.

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