Navigation Links
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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Creating a Platform for Managed Care Pull-Through Success in 2011
2. Sanofi-aventis to Acquire BMP Sunstone Creating a Strong Consumer Healthcare Platform in China
3. Creating Partnerships Across R&D and Marketing to Ensure a Successful Global Launch
4. Medco Completes Acquisition of United BioSource Corporation, Creating Powerful Engine for Rapidly Advancing Clinical Insight and Innovation
5. Graymark Healthcare Agrees to Sell Pharmacy Division to Walgreens Creating Pure Play Sleep Apnea Company
6. Empire BlueCross BlueShield Expands Lab Networks -- Creating Broader Choice, Robust Competition and Lower Costs for Consumers
7. Learn How Merck is Creating a Unified Culture and Company Brand During NewsGator Webinar Entitled: From MyMerck to OneMerck - Enterprise 2.0
8. Creating Healthcare Reform from the Inside Out Through Supply Chain Best Practices that Improve Financial and Clinical Performance is Focus of 2010 GHX Supply Chain Summit
9. Sanofi-aventis to Acquire Chattem Inc., Creating a Strong U.S. Consumer Healthcare Platform
10. CMS Admits New Surety Bond and Accreditation Requirement for Home Medical Equipment Suppliers Creating Patient Access Issues
11. New Study Published: Lactobacillus reuteri Prodentis Effective in the Treatment of Periodontitis
Post Your Comments:
(Date:11/25/2015)... November 25, 2015 Kitov Pharma ... (TASE: KTOV), a biopharmaceutical company focused on the development ... clinical conditions, today announced the closing of its previously ... ( ADSs ), each representing 20 ordinary shares of ... ADSs. The ADSs and warrants were issued in a ...
(Date:11/25/2015)... , Nov. 25, 2015  Trovagene, Inc. (NASDAQ: ... today announced that Chief Executive Officer Antonius Schuh, Ph.D., ... 27 th Annual Piper Jaffray Healthcare Conference. ... the New York Palace Hotel in New ... 1:30 p.m. EST. Mr. Schuh will be available for ...
(Date:11/25/2015)... , Nov. 25, 2015 Allergan ... pharmaceutical company, and Rugen Therapeutics, a start-up  biotechnology ... for unmet CNS disorders and funded by the ... they have entered into an exclusive collaboration to ... for Autism Spectrum Disorders (ASD) and Obsessive Compulsive ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... On November 25, 2015, ... for the Narconon network, announced the release of a new cutting edge recovery program ... organization has been working with drug- and alcohol-addicted individuals with the purpose to free ...
(Date:11/25/2015)... Lake, IL (PRWEB) , ... November 25, 2015 , ... ... to announce a recent successful appellate decision obtained by Attorneys Francisco J. Botto and ... case Adcock v. Illinois Workers’ Compensation Comm’n, 2015 IL App (2d) 130884WC. , According ...
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of Botox® for the ... of the benefits of Botox® in the treatment of moderate facial wrinkling, few have ... pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, and Bruxism (the ...
(Date:11/25/2015)... ... 2015 , ... Beddit® has launched a new Android app for ... features a more intuitive SleepScore™ that rates sleep quality on a 100-point scale and ... created by a proprietary algorithm. Beddit analyzes the data to provide an easy to ...
(Date:11/25/2015)... , ... November 25, 2015 , ... In an ongoing ... Medical Center (RMC) in Chicago, IL, UV Angel is evaluating the efficacy of its ... surgical intensive care units (totaling 30 beds) from May 2014 through October 2015 at ...
Breaking Medicine News(10 mins):