FDA Announces Effort to Promote Best Practices Across Advisory Committee
Meetings Program is Part of Management Modernization Effort Inside Drug Center
As part of the Food and Drug Administration’s (FDA) broader effort to modernize approaches to managing the new drug review process, the agency’s Center for Drug Evaluation and Research (CDER) is launching an internal assessment of its Advisory Committee Meeting system in order to establish best practices surrounding this important process.
Led by senior management from the Advisors and Consultants Staff, within CDER, this comprehensive look at 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 advisory committee process is an increasingly important part of our work, and this effort is aimed at identifying and elevating the best approaches to take full advantage of the committees’ function,” said Dr. Steven Galson, Director, Center for Drug Evaluation and Research. “This, in addition to other recent commitments, such as working to adopt new quality systems for the way we manage post market studies and meetings with sponsors will allow us to continue to make improvements in how we approach our daily mission.”
The primary role of an advisory committee is to provide expert, independent advice on complex scientific issues presented to 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 to address.
This advice contributes to the quality of the agency’s regulatory decision-making and lends credibility to the FDA decision-making process by having public discussions of controversial topics by the world’s experts, the Agency staff, and the Agency’s stakeholders.
Currently there are 16 standing advisory committees operating within CDER. To optimize and standardize practices across the Center, FDA is undertaking a comprehensive review of our processes in order to ensure consistency and to elevate best practices.
In addition to the issues above, this review will also involve meeting administration, such as development of the agenda, preparation of background materials and presentations, as well as crafting of the questions to the Committee for review, discussion and vote.
This review will begin immediately and is expected to take one year.
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