It really behooves regulatory professionals to be able to describe how a REMS might be used, when it may be required and how it may be used strategically.
Rockville, MD, USA (PRWEB) May 17, 2012
The Regulatory Affairs Professionals Society (RAPS) has published a new book to help those involved with the development and marketing of pharmaceutical and biologic products better understand and design Risk Evaluation and Mitigation Strategies or REMS. Authored by Edward Tabor, MD, vice president of the Strategic Drug Development Unit at Quintiles, Risk Evaluation and Mitigation Strategies for US Drug Development is an authoritative resource on REMS requirements, process and implementation. It is helpful for predicting whether the US Food and Drug Administration (FDA) may require REMS for new drug products and offers guidance on how to create and execute one.
The 2007 passage of the Food and Drug Administration Amendments Act (FDAAA) gave FDA the authority to require a REMS as a condition of approval for any product where agency reviewers determine the drug’s benefits would not outweigh the risk without some sort of additional control. REMS have since become a permanent fixture in the drug development process.
“Having a REMS is both a risk and an advantage,” said Tabor in an interview with RAPS’ Regulatory Focus . “There will be certain expenses and resources required but it may allow you to get out on the market sooner. It really behooves regulatory professionals to be able to describe how a REMS might be used, when it may be required and how it may be used strategically.”
The book consists of 14 chapters, covering topics including: The Limits of Risk and the Concept of the REMS; When Is a REMS Needed?; Components of a REMS; Preparing and Filing a REMS; Modifying a REMS; REMS for Entire Drug Classes; Effect of a REMS on the Speed of Review and Approval of New Drugs; The Impact of REMS on Generic Drug Approvals and Drug Competition; and Possible Future Changes to the REMS Process.
Risk Evaluation and Mitigation Strategies for US Drug Development is available for purchase online from the RAPS Store for $34.95 (US) for RAPS members or $44.95 for nonmembers.
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org