FDA issued its long awaited draft guidance, “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments and Proposed REMS Modifications”, on September 30. While much of the guidance is codification of what’s already been happening in practice over the past two years, there are a few surprises (indicated here in bold) for all of us working in the REMS space to contemplate. This is the first in a series of blog posts about this important document. (more…)
ParagonRx Blog
The latest in pharmaceutical appropriate use, risk management & REMS
News from ParagonRx- An Opportunity to Improve the FDA February 3, 2012This year, Congress will have to reauthorize the Prescription Drug User Fee Act (PDUFA), which funds the Food and Drug Administration’s (FDA) drug approval process. As noted by Amanda Kronquist, a Heritage Health Policy Graduate Fellow, the FDA drug... […]
- EMA planning fundamental change in pharmacovigilance rules February 3, 2012The European Medicines Agency, together with the European Union member states and the European Commission, is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change to the legal framework... […]
- inVentiv Medical Management Launches Accountable Care Solutions(TM) February 3, 2012inVentiv Medical Management, an inVentiv Health company and leading provider of physician-directed, nurse-supported and technology-enabled medical management solutions, announced today the national launch of a series of new solutions that help to prevent the inappropriate and ... […]
- Marijuana mouth spray: Will cancer pain reliever be abused? February 3, 2012The medical marijuana drug Sativex, which could be approved in the United States in the coming years as a treatment for pain relief, has little potential for abuse, experts say... ... […]
- An Opportunity to Improve the FDA February 3, 2012