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Creating an Effective Regulatory Affairs Group for NDA Interactions

CHAPEL HILL, N.C., Nov. 18, 2010 /PRNewswire/ -- Pharmaceutical companies with good track records of approvals and first approvals are characterized not only by strong science but also strong working relationships with the FDA. Regulatory Affairs is the function that oversees and guides interactions with the FDA - it's a job that comes with a plethora of responsibilities related to New Drug Applications (NDA). But organizations approach the subject of relationships differently and with strong concepts of what works and what doesn't work.

A Best Practices, LLC study, Building an Effective Regulatory Relationship with the FDA, found that 93 percent of regulatory leaders said it is highly effective to set roles for each speaker at a NDA Advisory Committee meeting. And 80 percent said conducting mock reviews is also a highly effective approach for preparing a team for an advisory committee meeting.

While conducting mock reviews and setting speaker roles were rated highly by regulatory leaders, one veteran said concentrating on the Q&A portion of the meeting was more important than focusing on presentations.

"I would challenge them that the original [presentation] draft is probably as significant as is the 19th draft. You have to be prepared and acknowledge the significance of the Q&A. We try to move away from providing answers to every possible question and try to focus in on the hot topics and follow through on those...," the Regulatory vice president said. "I have been through 11 [advisory committees] and I'm 10-1 on these."

"Building an Effective Regulatory Relationship with the FDA" delivers benchmarks and insights that identify effective interaction approaches for understanding and working with the FDA during the NDA process. Regulatory Affairs executives and managers can use this 80-page report to build better working relationships with the FDA by comparing their communication methods and policies with the practices of leading pharma companies.

The report contains metrics from regulatory operations at 15 bio-pharmaceutical companies and one medical device firm. In addition to quantitative data from a detailed survey, the research gleaned qualitative data from in-depth interviews with regulatory leaders at 13 of the companies. Participants included Merck, Bristol-Myers Squibb, Genentech, Lilly, Wyeth, Roche, Bayer, AstraZeneca, and Amgen.

To learn more about this new report, including information about the research participants, key findings and sample best practices, download a complimentary excerpt and study overview at:


Best Practices, LLC, conducts work based on the simple yet 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. Best Practices, LLC has been a leader in pharmaceutical research and consulting for 17 years; our clients include 48 out of the top 50 pharmaceutical companies. For more information visit:

SOURCE Best Practices, LLC
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