The FDA's New Adverse Reaction Early Warning System: How Will It Impact Your Approved Drugs and Biologics?

Presented by James M. Wood

Recorded On: Tuesday, August 31, 2010

Duration: 90 minutes

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RECORDING HIGHLIGHTS:

The FDA’s latest initiative will bring information about drug and biologic adverse events directly to patients and their health care providers. This program, a requirement of FDAAA (Section 915), will publish post-approval safety data on the FDA’s website. It is intended to act as an early risk notification mechanism.

This new initiative raises many questions for those in the drug and vaccine industries, such as:

What information will be posted?
What information will be excluded?
How will this affect approved drugs and biologics?

In this 90-minute audio conference, James Wood of Reed Smith will explain what you need to know about this new program from the FDA. He will discuss the background for the development of the alert system along with the potential impact for your products.

Questions To Be Answered:

What should you expect from the FDA’s website postings?
What can you do if you disagree with information posted about your products?
What are the implications of this program for product liability issues?
How will the program affect the prescribing decisions of health care providers?

Attendees Who Will Benefit From This Audio Conference Include:

Regulatory professionals
Marketing professionals
Legal counsel
Outside counsel

YOUR EXPERT(S):

James M. Wood
James M. Wood, Partner with Reed Smith, is an accomplished attorney with more than 30 years of experience representing both drug and medical device manufacturers. He has aided clients with recalls, marketing and promotion, off-label issues, preemption, product liability issues and the reuse of single use medical devices. He served as regional counsel for an international medical device company in a product liability action and was the multidistrict litigation (MDL) liaison counsel in the Gammagard® MDL litigation. James is a highly in-demand speaker for conferences, and is a prolific author of articles for legal publications and industry newsletters. He also co-authored Recalls of Prescription Product: A Proactive Primer, a book that details how to plan and implement the recall process for all regulated products. He earned his J.D. from the University of San Francisco.