Tag:
REMS
Latest Headlines
Latest Headlines
REMS costs calculated in study
At last! Some economic data on the impact of REMS, the FDA's risk evaluation and mitigation strategy program intended to ensure that drug benefits outweigh risks. The study, by the Center for
PPD, Microsoft team up for REMS management
Adding to Microsoft's growing presence in the clinical trial business, contract researcher PPD says it's working with the software giant on a solution for managing REMS programs. The partners have
Expert tips for REMS success
If recent events are any indicator, REMS programs are here to stay. Risk strategists are becoming as key to drug approval as manufacturing quality assurance. The FDA appears to be approaching its use
FDA makes REMS a drug approval staple
St. Louis-based law firm Bryan Cave expects the FDA to step up its risk evaluation and mitigation strategy activities in the coming year. "Stakeholders have expressed that they would like PDUFA V
REMS gets backlash from ESA, opioid camps
Most press coverage and conference presentations on the topic of risk evaluation and mitigation strategies include the message that REMS programs will become increasingly used by the FDA in drug
Report: Add REMS to Sentinel System
Risk Evaluation and Mitigation Strategies could become part of the solution to a pharma supply-chain nosebleed: Tainted chemicals from overseas. The Sentinel System for drug side-effect tracking,
FDA's Sharfstein talks REMS, track and trace
Be on the lookout for FDA guidance on unique identification for prescription drug packages, says FDA principal deputy commissioner Joshua M. Sharfstein, speaking to the U.S. House of Representatives
REMS sans registry may get one
In backing the approval of InterMune's pirfenidone for idiopathic pulmonary fibrosis, an FDA panel voted that the drug's safety had been adequately assessed, despite some concerns. Panelists urged
New website serves REMS writers
Consultancy BioTrak Market Intelligence has launched REMSadvisor.com , a resource for those developing risk evaluation and mitigation strategies. REMS have become an increasingly required approval
REMS on the rise
Add three more drugs whose commercial availability is contingent on a risk evaluation and mitigation strategy: Aranesp, Epogen and Procrit. All three are erythropoiesis-stimulating agents (ESAs) made
