The US Food and Drug Administration?s (FDA, Rockville, MD, www.fda.gov) Center for Drug Evaluation and Research (CDER) is studying its own Advisory Committee Meeting system to identify best practices for this process.
The US Food and Drug Administration's (FDA, Rockville, MD, www.fda.gov) Center for Drug Evaluation and Research (CDER) is studying its own Advisory Committee Meeting system to identify best practices for this process. Senior managers from CDER's Advisors and Consultants staff will lead the assessment, examining current practices for nominating members, choosing consultants with appropriate expertise, developing competing-products lists, screening for conflicts of interest, engaging special government employees outside of advisory-committee meetings, and other areas.
Advisory committees are established to provide expert, independent advice on complex scientific issues FDA must consider when making regulatory decisions. The review is expected to take one year and is part of FDA's larger effort to modernize approaches to managing the new-drug review process.
