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21st Century Cures: A Regulatory Game-Changer for the Pharmaceutical Industry

CHAPEL HILL, N.C., April 17, 2015 /PRNewswire/ -- Regulatory leaders in the pharmaceutical industry continue to watch closely the newly released bipartisan discussion draft called "21st Century Cures."

This 393-page draft document is planned to be taken up by Congress soon and if enacted into law, it could alter how pharmaceutical and medical device products are developed and marketed in the United States. For that reason, many companies have begun to consider how the proposed changes could impact their corporate strategies and the competitive landscape in the future.

Research and consulting firm Best Practices, LLC has published a white paper, "21st Century Cures Initiative Leads The Way For Change," to inform leaders about five key regulatory issues in the 21st Century C"ures Initiative, including:
  • Patient-Focused Drug Development (PFDD) patient experience data incorporation into regulatory decision-making
  • Expanded Access/ Compassionate Use requirements for certain drug/device designations
  • Real World Evidence (RWE) utilization to supplement clinical trials for other indications
  • Social Media regulations that are more lucidn ad liberal
  • Adaptive Clinical Trials and Bayesian Statistics used more broadly

This white paper details each of the five regulatory issues that have the attention of both the pharmaceutical industry leaders and politicians. It is crucial for pharmaceutical executives to be ahead of the game by analyzing the proposal and creating possible internal changes around critical aspects of the impending legislative action.

To learn more about this report, download a complimentary report excerpt at

For related research, visit our Best Practices, LLC Web site at


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. Best Practices, LLC believes in the profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies.

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