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Recent Research Provides Formula for Timely Product Launch: Good Science + Effective FDA Relations
Date:10/24/2011

CHAPEL HILL, N.C., Oct. 24, 2011 /PRNewswire/ -- Two of the most crucial components of a successful new product launch application are good science and strong working relationships with the FDA. However, while building a collegial and effective working relationship with reviewers, directors and project managers at the FDA is not always an easy task, not doing so can cause significant approval delays.  

One study participant, a Regulatory Affairs Executive Director at a leading pharmaceutical company emphasizes this point: "You can't just have anybody picking up the phone and calling people at the FDA. Regulatory should be in the mix even if it is an informal dialogue from top level down to statisticians talking to the FDA."

According to the latest Best Practices, LLC, study, Building an Effective Regulatory Relationship with the FDA (click link to download complimentary research excerpt), 62 percent of survey participants opt for a highly centralized approach to oversight of FDA.

Interviews and key insights in this study are drawn from leaders at 16 leading biopharmaceutical companies, including Alcon, Amgen, Bayer, Eli Lilly, Genentech, Merck, Roche and Solvay. This Best Practices, LLC report delivers benchmarks and insights that identify approaches for understanding and effectively interacting with the FDA.

The full 80-page report contains more than 250 metrics and scores of narratives that companies can use to build better working relationships with the FDA by comparing their communication methods and policies with the practices of leading pharmaceutical companies. Key topics of this primary research include:

  • Organizational structure and alignment
  • Regulatory skill sets
  • Relationship management
  • Planning for critical FDA meetings
  • Understanding FDA
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SOURCE Best Practices, LLC
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