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According to industry experts, the impact of the updated REMS policy in 2007 has had limited impact on the industry thus far.
The FDA was granted expanded authority to require REMS (risk evaluation and mitigation strategies) for new drug applications or for existing drugs where the FDA has determined that REMS are necessary to ensure that the benefits of a drug outweigh the risks.
REMS should include specific, measureable goals to demonstrate particular health outcomes or knowledge related to risk, our experts say. Additionally, REMS may include a communication plan targeted at healthcare providers and medication guides for patients. Periodic assessments of the targeted audiences…
Experts on this topic
Darshan Kulkarni, Pharm.D., Esq., Principal Attorney at Kulkarni
David Selkirk, Senior Director at Clinimetrics
Doreen Moran, Senior Digital Strategist at Sudler Digital
Kathy Bronshtein, Senior VP, Chief Compliance Officer, at Sudler & Hennessey
R. Shane Kennedy, Executive VP, Managing Director, at Sudler Digital
John Hall, Global Medical Affairs, Epidemiology and Outcomes Research, at Quintiles
Michael Parisi, President of Altum, part of CommonHealth
Cynthia Verst, Pharm.D., Senior VP, Late Phase Research, at i3 Innovus
Patrick Chassaigne, Director, Late Phase Solutions, at Medidata Solutions