Led by senior management from the advisors and consultants staff, within the Center for Drug Evaluation and Research (CDER), this examination of current practices will include the processes for nominating members, choosing consultants with expertise specific to the meeting topic, developing competing products lists, screening for conflict of interest, and utilizing special government employees outside of an advisory committee meeting.
“This is part of an overarching quality systems improvement process within CDER designed to advance our approach to managing the review process, whether it is through process improvements in our own scientific work, through quality systems we adopt, or through technological improvements such as the incorporation of information technology to help us better evaluate the information we receive,” said Dr Scott Gottlieb, deputy commissioner for medical and scientific affairs. “The idea is to identify best practices and adopt them center-wide to improve the consistency and predictability of the work we do.”
The primary role of an advisory committee is to provide expert, independent advice on complex scientific issues presented to the FDA. These issues range in scope from the approvability of new products to the review of reported adverse events after a product has been marketed. At times, the nature of the questions considered by FDA requires the agency to seek outside scientific and technical expertise.
The review will begin immediately and is expected to take one year.