CHAPEL HILL, N.C., July 17, 2017 /PRNewswire/ -- It has been 10 years since the U.S. Food and Drug Administration gainedthe authority to require pharmaceutical companies to develop Risk Evaluation and Mitigation Strategies (REMS) for products that may have safety issues.
Given the complexity of balancing regulatory requirements and commercial objectives, research
The study found that most companies have relatively limited experience in implementing a REMS plan. On average, benchmark companies have only deployed REMS plans for 4.7 products since the Food and Drug Administration's Amendments Act of 2007 was issued. With REMS requirements so infrequent for most drug manufacturers, it is critical to leverage as much internal experience as possible.
In particular, the study provides insights around the structure and responsibilities of REMS teams, use of internal and external resources to support REMS programs, physician/ distributor compliance, current challenges in REMS communication plans and innovative REMS approaches for new products.
Key topics covered in this new report include:
The study is based on insights from 20 leaders from 17 leading biopharmaceutical and medical device companies.
To learn more about this report, download a complimentary report excerpt at http://www.best-in-class.com/rr1456.htm.
For related research, visit our Best Practices, LLC Web site at www.best-in-class.com/.
ABOUT BEST PRACTICES, LLC
Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis.
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SOURCE Best Practices, LLC
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