Howell is an anatomic and clinical pathologist well-known for her work to improve protocols for prevention, diagnosis and treatment of breast and cervical cancer. A pioneer in new methods for cervical cancer screening, Howell led clinical testing of liquid-based Pap tests and computer-assisted screening, leading to FDA approval and national implementation of these technologies, which now set the standard of care.
"Advice by medical professionals is a key part of the FDA's review process," Howell said. "I'm honored to have been chosen to lead this panel and to play a role in bringing safe, effective and innovative new devices to market that will benefit the delivery of patient care in hematology and pathology."
Howell has participated in national consensus conferences, committees and panels for the National Cancer Institute, Centers for Disease Control and Prevention, the College of American Pathologists and the California Department of Public Health. This participation has contributed to the development of a national uniform terminology for gynecologic cytology, algorithms and guidelines for breast and cervical cancer screening and management of abnormal results. It also has contributed to the uniform practice of breast fine-needle aspiration and laboratory accreditation and quality improvement programs.
The FDA's Center for Devices and Radiological Health has established advisory committees to provide independent, professional expertise and technical assistance on the development, safety and effectiveness and regulation of medical devices and electronic products that produce radiation. Each committee consists of experts with recognized expertise and judgment in a specific field.
Members have the training and experience necessary to evaluate information objectively and to interpret its significance. These individuals are not regular employees of the FDA, but are paid as "special government employees" for the days they participate as members of a panel. This is time they take from their daily occupations to provide their professional skills to FDA. The committees are advisory — they provide their expertise and recommendations — but final decisions are made by the FDA.
The center has four advisory committees, including a Medical Devices Advisory Committee, which consists of 18 panels that cover the medical specialty areas. The Hematology and Pathology Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine, including pathology, hematology, histopathology, cytotechnology and molecular biology and makes appropriate recommendations to the commissioner of food and drugs.
The most recent activity of the Hematology and Pathology Devices Panel was a two-day meeting to gather expert opinion on digital, whole-slide imaging. Several devices have been approved by the FDA for limited applications. At issue is whether these technologies can be used safely and effectively to render pathologic diagnoses of routine surgical specimens.
The UC Davis School of Medicine is among the nation's leading medical schools, recognized for its research and primary-care programs. The school offers fully accredited master's degree programs in public health and in informatics, and its combined M.D.-Ph.D. program is training the next generation of physician-scientists to conduct high-impact research and translate discoveries into better clinical care. Along with being a recognized leader in medical research, the school is committed to serving underserved communities and advancing rural health.