Drugs

FDA Names Veteran Investigator as Head of Inspections/Investigations

FDA has appointed Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency veteran to one of the top leadership positions within the agency's inspection and enforcement organization. She replaces Douglas Stearn who retired late last year.

Romano, who most recently served as deputy director of the FDA's Medical Products Inspectorate, will help oversee the agency's Office of Inspections and Investigations (OII), which is responsible for inspections, investigations, import oversight, and other field operations supporting FDA's public health mission.

The appointment places a longtime field operations and enforcement official in a key leadership role at a time when the FDA continues to modernize its inspection programs and strengthen oversight of global supply chains.

Romano has spent her entire FDA career in the agency's field organization, formerly known as the Office of Regulatory Affairs (ORA), according to her bio. She began as a consumer safety officer, working on import operations, food inspections, and medical product recall audits before moving into a series of enforcement and management positions.

Romano later assumed leadership roles in ORA's Office of Regional Operations, which oversaw inspections, investigations, import operations, laboratory activities, emergency response efforts, and state partnerships. During that period, she played a role in several initiatives that have since become central to FDA field operations, including development of the agency's quality management system, implementation of the FDA's third-party audit program, and expansion of environmental sampling activities.

FDA said Romano also has extensive experience working with foreign regulatory agencies. She served for nearly a decade as ORA's representative to the Codex Committee on Food Import and Export Inspection and Certification Systems and worked with counterparts at Health Canada and the European Commission's Directorate-General for Health and Food Safety (DG SANTE) on international regulatory initiatives.

In addition to her inspection and enforcement experience, Romano has held temporary leadership assignments as New England district director, deputy director of ORA's Office of Resource Management, and deputy director in the FDA's Center for Food Safety and Applied Nutrition Office of Compliance.

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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’

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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