A Review of US REMS Regulation and Compliance
A new whitepaper published by iReminder, LLC provides guidance on meeting FDA requirements set forth in the Food and Drug Administration Amendments Act of 2007 (FDAAA) for products with known or potential risks. This paper reviews mandated enforceable guidelines, called Risk Evaluation and Mitigation Strategies (REMS), and covers the strengths and challenges of existing implementations.
iReminder’s Risk Mitigation Regulation and Compliance Review guides pharmaceutical and biotech companies tasked with implementing REMS programs on system design and implementation to both protect patients and provide an economic upside.
The recommendations are based on several case studies of systems built to meet a rigorous REMS requirement, called Elements to Assure Safe Use (ETASU). Included in the review are Roche’s iPLEDGE™ program for Accutane (isotretinoinoin), Amgen’s APPRISE erythropoiesis stimulating agents (ESA) class-wide program, and Gilead’s LEAP program for Letairis® (ambrisentan).
“Based on this extensive review, we were able to assemble a list of best practices and recommendations for designing REMS ETASU programs,” said Jean Steckler, senior vice president of iReminder. “Optimal programs automate tracking to avoid burdening the health care providers and pharmacies,” she added.
Recommendations for designing efficient REMS ETASU programs include:
• Automated IVR, email and SMS messages to patients to remind them of upcoming laboratory testing and refill dates
• Automated alerts to HCP and pharmacies when patients report that they will not comply with laboratory testing or refill pick ups
• Automated distribution and printing of Medication Guides at the pharmacy and HCP office
• Online access for: − Pharmacies to determine certification status of HCPs − Prescribers to determine certification status of pharmacies − Wholesalers to determine certification status of pharmacies − HCP and pharmacy training and certification
• Online storage of HCP and Patient Agreement documentation
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
