FDA Advisory Committee Survival Strategies: The Road To Approval

NEW EBI Webinar: FDA Advisory Committee Survival Strategies: The Road To Approval

January 20, 2010 at 2:00 pm EDT Click Here To Register!

Getting a drug or medical device to market has never been more expensive, time-consuming, or difficult. New legislation increases the likelihood that your product will wind up in front of an FDA advisory committee. With the road to approval becoming even tougher, just having solid data to support your product may not be enough.

Knowing how to avoid common pitfalls, effectively present your story to an increasingly skeptical audience, and manage Q&A can make or break your new drug or device application.

In this Webinar (January 20 at 2:00 pm EDT) sponsored by "The Pink Sheet" and "The Gray Sheet" - our experts will take you through a strategic approach to preparing for an advisory committee that maximizes your chance of success, no matter your level of experience in this challenging process.

Click Here To Register!

Knowing how to avoid common pitfalls, effectively present your story to an increasingly skeptical audience, and manage Q&A can make or break your new drug or device application.

In this Webinar (January 20 at 2:00 pm EDT) sponsored by "The Pink Sheet" and "The Gray Sheet" - our experts will take you through a strategic approach to preparing for an advisory committee that maximizes your chance of success, no matter your level of experience in this challenging process.

Click Here To Register!

Experts agree that the advisory panel process itself has changed. Because of tighter conflict-of-interest rules, panelists tend to be less well-informed about your product and indication, and more concerned than ever about product safety. The combination makes for a particularly challenging meeting. But there are strategies and processes that can help you prepare your team, better explain the issues, and increase your chances for product approval.

We bring you seasoned veterans who have successfully steered Rx drugs and first-in-class switches through the approval process. Presenters include:

• Deborah Henderson, Director, Office of Executive Programs, Center for Drug Evaluation & Research, FDA
• Bruce Burlington, Former Director, Center for Devices & Radiological Health, FDA 
• William Pullman, Former Executive VP and Chief Development Officer, Dyax

For more information and to register: Click Here

We bring you seasoned veterans who have successfully steered Rx drugs and first-in-class switches through the approval process. Presenters include:

• Deborah Henderson, Director, Office of Executive Programs, Center for Drug Evaluation & Research, FDA
• Bruce Burlington, Former Director, Center for Devices & Radiological Health, FDA 
• William Pullman, Former Executive VP and Chief Development Officer, Dyax