Morgan Lewis on Life Sciences
October/November 2005

In This Issue:

• Manufacturing Outsourcing in the Medical Device Industry: An Overview of the Process and Key Legal Issues:
  In today’s increasingly competitive global economy, medical device companies are continually seeking ways to drive down production costs while at the same time improve quality and accelerate time-to market. Outsourcing the manufacturing and assembly of medical devices or components thereof to a third party – whether onshore or offshore – may serve as an efficient and costeffective way to achieve these goals. While outsourcing is by no means a new concept for the medical device industry, its scope, and the types of outsourcing being used, have increased in the last couple of years.
• Keeping Watch: The FDA's New Drug Watch Program:
  In the wake of well-publicized and aggressively litigated claims regarding Cox-2 inhibitors, diet drugs and other pharmaceutical products, the FDA became the target of criticism from the public, industry analysts and elected officials. Among the criticisms were complaints that the FDA had become too close with the manufacturers it regulates and that it did not sufficiently warn the public about certain products’ post-approval adverse events or emerging signs of potential injury.
• Events, Speeches, and Articles

For the full story, please view the PDF.