Compliance Zen

FDA Regulatory Outlook and Forecast 2010 Newsletter Issue Available

My annual FDA regulatory forecast and planning issue of my SmarterCompliance newsletter has been published. In the December newsletter:

• 35 predictions for FDA activities for the coming year plus 30 specific recommendations
• Featured reading: The Predictioneer's Game
• Bonus downloads: 
• • 10 pages of analyses and recommendations on trends in new drug / device development
  • Report on the regulatory harmonization and collaboration between FDA and EMEA
  • Excerpt from my forthcoming book, Get to Market Now!, slated for publication in May 2010

You can a lot more content and bonus downloads with a full subscription to my monthly FDA newsletter here:   http://www.ceruleanllc.com/Newsletter/Subscribe.htm

Join my Cerulean mailing list here:  http://www.ceruleanllc.com/ContactReq.aspx

The first draft of the book manuscript is currently being slashed and burned by my editor at Logos Press in D.C. The next few weeks promise an unhealthy mix of gift-wrapping and manuscript revisioning. The goal is to get the book to the printers by January so it's ready for publication to coincide with BIO 2010. The book is all about regulatory compliance and quality systems over the next decade, from 2010 - 2020, and is a blueprint, if you will, of what biopharmaceutical and device executives need to do in order get their new drugs and devices on the market as we increasingly face medicine personalization, reimbursement challenges, and globally harmonized regulations. It, as my editor has at least graciously allowed, "a blueprint for success."

Over the coming months, I'm building a special website dedicated to the book with downloads, mini-seminars, and chapter extracts.

In two weeks, just after Christmas holidays here in the States, the December issue of my newsletter will be released with all my various FDA forecasts and recommendations for 2010. So stay tuned!