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Risk Evaluation and Mitigation Strategy (REMS) - Opioids, Erythropoesis-Stimulating Agents and Cancer Therapeutics are the Most Important Classes That Require REMS
GBI Research, May 2011, Pages: 88
“Risk Evaluation and Mitigation Strategy (REMS) - Opioids, Erythropoesis-Stimulating Agents and Cancer Therapeutics are the Most Important Classes That Require REMS”, provides key data, information and analysis on the risk management and mitigation strategies, mandated by the FDA and being implemented by pharmaceutical companies. The report provides information on the Risk Evaluation and Mitigation Strategies (REMS), the reasons why companies implement REMS and the importance of REMS.
This report provides comprehensive analysis of REMS approved up to date, components of REMS and safety issues involved in the requirement of REMS using case studies. Also, information on major drug classes that require REMS such as opioids and erythropoesis-stimulating agents in cancer management is also provided in detail. The report also reviews the impact of REMS on various stakeholders including patients, healthcare providers and pharma and biotech industries. Selected REMS consulting companies are covered in the report.
This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by a team of industry experts.
The increasing number of deaths due to adverse reactions has been alarming and has forced the FDA to implement strict regulatory guidelines for drug use. For every drug approved by the FDA, potential risks or adverse reactions of the drug are communicated to the patients and physicians through product package inserts. However, drug withdrawals such as the highly publicized Vioxx withdrawal in 2004 brought the FDA under scrutiny and highlighted the need for fundamental changes in the system.
Scope
- Analysis and data on REMS, detailed review of the drug development and pharmacovigilence studies, the need for REMS and implementation of the Food and Drug Administration and Amendments Act (FDAAA) by the FDA
- Insight into the number of approved and deemed REMS since the FDAAA came into effect.
- Components of REMS and the increasing complexity of the same.
- Analysis of the safety issues and different therapy areas that have seen REMS approvals.
- Detailed analysis of important drug classes that require REMS including opioids, and erythropoesis-stimulating agents in cancer management.
- Overview of consulting companies that offer risk management services and selected case studies.
Reasons to buy
The report will enhance your decision making capability. It will allow you to -
- Build understanding of REMS for current drugs on the market and the need for REMS for new drugs and the process of submission.
- Develop effective business strategies related to risk mitigation and management of present drugs on the market and drugs in the pipeline that may require REMS.
- Analyze the safety issues and drugs in key therapy areas that require REMS and develop effective strategies to prevent a drug’s withdrawal from the market.
- Identify the key consulting companies that offer risk management solutions.
- Identify and understand various IT tools for effective data management and as a result, easy documentation of REMS.
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