Equal Voice and Dispute ResolutionWhen any regulatory action or policy decision is considered, FDAs Center for Drug Evaluation and Research (CDER) must reach an institutional position. The process is complex and may involve primary reviewers, team leaders, supervisors, and managers within one or more organizational components. The Manual of Policy and Procedures (MaPPs) and on-line training course that were developed to train CDER staff (<a href= http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/ucm229014.pdf target=”_blank”>Equal Voice</a>, (<a href= http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/ucm073558.pdf target=”_blank”>Differing Professional Opinions</a>, Dispute Resolution) have been completed and are currently in use to help clarify, discuss, and rectify issues that may arise within drug review teams related to professional differences of opinion. The implementation of these educational devices ensures that all CDER personnel will have an equal chance to voice their opinion, and that any disputes will follow a defined process to reach a resolution.
COMPLETEDON TRACK1. Finalize Manual of Policy and Procedures (MaPPs) for Equal Voice, Differing Professional Opinions (DPO), and Dispute Resolution4/1/2010Completed4/1/20102. Develop an on-line training course11/1/2010Completed11/1/20103. Negotiate with National Treasury Employees Union (NTEU) regarding mandatory training with testing to determine effectiveness of the training9/1/2010Completed9/1/20104. Implement training: Train at least 25 percent of CDER staff8/31/2011Completed9/1/2011