FDA Policy/General

CDER’s Rosemary Roberts is Retiring

After 35 years at FDA, CDER Counterterrorism and Emergency Coordination Staff (CTECS) director Rosemary Roberts is retiring this month. Roberts has served in her current position since 2004. Previously, she was the medical team leader for the Pediatrics Team and chair of the Pediatrics Subcommittee, where she worked to implement Section 111 of the FDA Modernization Act of 1997 on pediatric drug studies.

In her current role, Roberts and her staff work with sponsors who are developing countermeasures against chemical, biological, radiological, and nuclear threats throughout development, including at the pre-investigational and new drug application stages. She also led FDA efforts to implement the “Animal Rule” and emergency use authorizations. “Rosemary led collaborative cross-center and inter-agency work resulting in the publication of the 2015 final guidance on developing products under the Animal Rule and is known for her expertise on animal models and the Animal Model Qualification Program,” an agency email announcing her retirement says.

CTECS associate director Kelly Ngan will serve as acting director until Roberts replacement is selected.

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