Morgan Lewis on Life Sciences
February/March 2006

In this Issue:

• The Increasing Role of Congressional and Advocacy Strategies for Life Sciences Products:
  In view of recent widely publicized issues regarding lobbyists' activities and ethics, many life sciences companies are taking a hard look at their congressional and advocacy strategies and Washington D.C. representatives. For the FDA-regulated industry, having a congressional and advocacy strategy in place is an increasingly critical element of both an overall product strategy and maintaining a successful Washington presence.
• U.S. v. Utah Medical Products:
  On October 21, 2005, the U.S. District Court for the District of Utah, Central Division, dismissed the FDA’s request for a permanent injunction against Utah Medical Products (Utah Medical), stemming from alleged violations of the Quality System Regulation (QSR), 21 C.F.R. Part 820 (also referred to as Good Manufacturing Practices, or GMPs).
• Events, Speeches, and Articles

For the full story, please view the PDF.