FDA Approvals - Analysis: User Fees Could Help, Hurt FDA (RedNova) By OLGA
Analysis: User Fees Could Help, Hurt FDA (RedNova)
By OLGA PIERCE User fees have made Food and Drug Administration drug reviews faster, but as Congress debates reauthorizing the legislation that created the fees, a growing number of policymakers and advocates are questioning whether they have made the public safer.
NEJM Publishes Several Perspectives On FDA User Fee Reauthorization, Prescription Drug Safety (Medical News Today)
Drug Safety Reform at the FDA -- Pendulum Swing or Systematic Improvement?" New England Journal of Medicine: In the perspective, former FDA Commissioner Mark McClellan discusses an Institute of Medicine report that focused on FDA drug approval and postmarket safety and how recommendations could affect user fee reauthorization (McClellan, NEJM, 4/13). [click link for full article]