FDA Putting System In Place For RiskMAP Evaluation And Management
Executive Summary
FDA is trying to provide clarity on its risk management plan program by creating a Web site that will serve as a central source of risk management plan information
You may also be interested in...
FDA’s Drug Safety Office Reorganizing To Accommodate Influx Of PDUFA Staff
FDA's Office of Surveillance and Epidemiology is again undergoing changes as the agency continues to strengthen its drug safety operations. OSE is reorganizing prior to increasing staff by 50 percent to undertake new regulatory authorities
FDA’s Drug Safety Office Reorganizing To Accommodate Influx Of PDUFA Staff
FDA's Office of Surveillance and Epidemiology is again undergoing changes as the agency continues to strengthen its drug safety operations. OSE is reorganizing prior to increasing staff by 50 percent to undertake new regulatory authorities
FDA Reform Bill Will Keep Firms Scrambling To Stay Ahead On Safety Issues
Pharmaceutical companies need to immediately begin assessing whether their drugs are subject to the risk evaluation and mitigation strategies provisions of the FDA Amendments Act, participants were warned during a Food and Drug Law Institute audioconference on the new law, Oct. 4