FDA Track Record In Risk Communication Raised As Key Sentinel Concern
Executive Summary
FDA's ongoing challenges with effectively communicating the risks indicated by postmarket safety signals need to be resolved before the agency activates its Sentinel surveillance program, a number of participants said during a Dec. 16 FDA workshop
You may also be interested in...
FDA Surveying Doctors To Assess Impact Of Early Risk Communications
Findings from an FDA survey of physicians about their use and perceptions of emerging drug risk information could add a new tenor to the debate over the value of communicating early risk signals
FDA Surveying Doctors To Assess Impact Of Early Risk Communications
Findings from an FDA survey of physicians about their use and perceptions of emerging drug risk information could add a new tenor to the debate over the value of communicating early risk signals
FDA Post-Market Safety Efforts Won’t Be Impacted By Sentinel In Near Term
FDA's Sentinel post-market safety monitoring project will augment, not replace, the agency's current repertoire of post-market activities and requirements for drugs, Center for Drug Evaluation and Research Director Janet Woodcock emphasized