FDA meets to hear from the REMS Community

The InVivo blog covered the recent meetings the FDA held with Risk Evaluation & Mitigation Strategy authorities. Stakeholders presented over 70 different presentations to discuss how to safely and effectively market drugs. For all the coverage, InVivo mentions coverage of the proceedings are available at The Pink Sheet, The Pink Sheet DAILY, and The RPM Report. The two days spent with the FDA show the importance that they will be placing on REMS in the future.


This September, drug safety professionals will also be convening in Baltimore for the The Safety Continuum in the Medical Product Life Cycle event. During this three-day conference, experts offer strategies to overcome critical drug safety challenges faced through-out a product’s life cycle from premarketing clinical trials all the way to postmarketing safety surveillance/vigilance, and risk management. Participants learn about current regulatory national and international standards, state-of-the art methods and techniques in premarketing testing and evaluation, quality safety-related compliance and procedures, effective signal detection and assessment, adverse event reporting, and the latest risk management approaches in the US and abroad.