Pharmaceutical Processing Magazine Cover Features Cerulean’s 2009 FDA Forecast Under the Obama Administration
Under the Democratic Congress and the Obama administration, the US Food and Drug Administration will take an increasingly tougher line with pharmaceutical, biotech and medical device executives; this according to a new analysis published last week in Pharmaceutical Processing magazine.
Williamsburg, VA, January 29, 2009 --(PR.com)-- The FDA will likely be more aggressive in 2009, or so says an analysis published in the January issue of Pharmaceutical Processing magazine released last week.
The magazine’s cover feature and lead article, “FDA Forecast 2009 – Nine Recommendations to Weather the New Year,” discusses nine key initiatives the FDA is expected to undertake with its new leadership under the Obama administration. Written by John Avellanet, the Managing Director of Cerulean Associates LLC, the article discusses increased FDA enforcement and corporate scrutiny, anticipated regulatory changes, and new or revised guidance documents to be released. Each analysis is accompanied by recommendations for pharmaceutical, biotechnology and medical device management teams.
The article’s analyses and recommendations are part of the larger annual forecasting and planning report issued by Mr. Avellanet to members of his private SmarterCompliance advisory program. Mr. Avellanet was approached last year by the Editor-in-Chief of Pharmaceutical Processing, to make public some of the SmarterCompliance forecasting report.
“The January issue of Pharmaceutical Processing has traditionally been our ‘Industry Outlook’ issue. Knowing that 2009 was shaping up to be a bellweather year for the industry, I approached Mr. Avellanet late in 2008 to write an article based on his deep knowledge and experience on regulatory compliance issues,” said Editor-in-Chief, Mike Auerbach. “His article provides the readers of Pharmaceutical Processing with concise, informative, and actionable information that they can use throughout the year.”
Mr. Avellanet has nearly two decades of experience with regulatory compliance, research and development product commercialization and quality systems, particularly in the areas of preclinical, quality by design, Part 11 and Annex 11 compliance, and preventing intellectual property theft by insiders and partners. Mr. Avellanet is a co-author of the book Best Practices in Biotechnology Business Development, and writes and publishes the monthly executive regulatory intelligence and modern quality systems newsletter, SmarterCompliance™.
Mr. Avellanet expanded upon his analyses of expected FDA enforcement priorities and his recommendations in his January executive teleconference, “Bulletproof Yourself against FDA Enforcement in 2009” (a recorded version is available). To learn more about having Mr. Avellanet speak for your organization or conduct an on-site workshop for your company, please contact him directly: john @ceruleanllc.com.
Pharmaceutical Processing is the only pharmaceutical publication focused on delivering practical information through comprehensive updates on trends, techniques, services and new technologies. Designed to assist the industry professional in their day-to-day job functions and in turn, help their companies bring new drugs to market faster, with greater efficiency and the highest quality, Pharmaceutical Processing delivers must-have content to more than 31,000 subscribers world-wide. On the web at www.pharmpro.com.
Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at www.ceruleanllc.com.
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The magazine’s cover feature and lead article, “FDA Forecast 2009 – Nine Recommendations to Weather the New Year,” discusses nine key initiatives the FDA is expected to undertake with its new leadership under the Obama administration. Written by John Avellanet, the Managing Director of Cerulean Associates LLC, the article discusses increased FDA enforcement and corporate scrutiny, anticipated regulatory changes, and new or revised guidance documents to be released. Each analysis is accompanied by recommendations for pharmaceutical, biotechnology and medical device management teams.
The article’s analyses and recommendations are part of the larger annual forecasting and planning report issued by Mr. Avellanet to members of his private SmarterCompliance advisory program. Mr. Avellanet was approached last year by the Editor-in-Chief of Pharmaceutical Processing, to make public some of the SmarterCompliance forecasting report.
“The January issue of Pharmaceutical Processing has traditionally been our ‘Industry Outlook’ issue. Knowing that 2009 was shaping up to be a bellweather year for the industry, I approached Mr. Avellanet late in 2008 to write an article based on his deep knowledge and experience on regulatory compliance issues,” said Editor-in-Chief, Mike Auerbach. “His article provides the readers of Pharmaceutical Processing with concise, informative, and actionable information that they can use throughout the year.”
Mr. Avellanet has nearly two decades of experience with regulatory compliance, research and development product commercialization and quality systems, particularly in the areas of preclinical, quality by design, Part 11 and Annex 11 compliance, and preventing intellectual property theft by insiders and partners. Mr. Avellanet is a co-author of the book Best Practices in Biotechnology Business Development, and writes and publishes the monthly executive regulatory intelligence and modern quality systems newsletter, SmarterCompliance™.
Mr. Avellanet expanded upon his analyses of expected FDA enforcement priorities and his recommendations in his January executive teleconference, “Bulletproof Yourself against FDA Enforcement in 2009” (a recorded version is available). To learn more about having Mr. Avellanet speak for your organization or conduct an on-site workshop for your company, please contact him directly: john @ceruleanllc.com.
Pharmaceutical Processing is the only pharmaceutical publication focused on delivering practical information through comprehensive updates on trends, techniques, services and new technologies. Designed to assist the industry professional in their day-to-day job functions and in turn, help their companies bring new drugs to market faster, with greater efficiency and the highest quality, Pharmaceutical Processing delivers must-have content to more than 31,000 subscribers world-wide. On the web at www.pharmpro.com.
Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at www.ceruleanllc.com.
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Cerulean Associates LLC
John Avellanet
757.645.2864
www.ceruleanllc.com
John Avellanet
757.645.2864
www.ceruleanllc.com
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