Navigation Links
Creating an Effective Regulatory Affairs Group for NDA Interactions
Date:11/18/2010

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: http://www3.best-in-class.com/rr1030.htm

ABOUT BEST PRACTICES, LLC

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: http://www3.best-in-class.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:6/2/2017)... , June 2, 2017  NxStage Medical, Inc. (Nasdaq:  NXTM), a ... today announced new findings demonstrating positive biochemical outcomes related ... System One™. The data will be presented at the ... Madrid, Spain . The ... Home Dialysis Network in Europe ...
(Date:5/29/2017)... Israel, May 29, 2017  Cellect Biotechnology Ltd. (NASDAQ: ... technology which enables the functional selection of stem cells, ... for the first quarter ended March 31 st , ... our accomplishments in the first quarter of 2017," said ... quarter, we announced the treatment of the first blood ...
(Date:5/22/2017)... VALLEY COTTAGE, N.Y. , May 22, 2017 ... natural antiviral treatment Gene-Eden-VIR/Novirin, announces the launch of ... in plain English, the results of a clinical ... after one year treatment with Gene-Eden-VIR/Novirin in individuals ... is important to note that there are no ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... June 23, 2017 , ... MD Now Urgent Care ... MD Now’s 28th facility overall and marks the urgent care center's eighth location in ... North of The Falls shopping mall. The new clinic offers a wide array of ...
(Date:6/23/2017)... ... ... American Farmer, will feature Chr. Hansen, Inc (CHR Hansen) in an upcoming episode ... Farmer airs Tuesdays at 8:30aET on RFD-TV. Check your local listings for more info. ... 1874 after a groundbreaking discovery of how to industrialize enzymes. Rooted in science and ...
(Date:6/23/2017)... Chicago, IL (PRWEB) , ... June 23, 2017 ... ... insurance management assistance and financial planning services to communities in the greater Chicago ... Children’s Association to offer assistance to underprivileged youth in Chicago. , Founded in ...
(Date:6/23/2017)... ... June 23, 2017 , ... Moore Insurance, ... area with access to asset protection and financial planning services, is teaming up ... improving the lives of children with cancer and other chronic diseases. , The ...
(Date:6/22/2017)... ... June 22, 2017 , ... ... is pleased to welcome Whipple & Company as its newest Partner Firm. Headquartered ... of balancing their clients’ risk while tailoring optimized benefit packages that strengthen the ...
Breaking Medicine News(10 mins):