Envisioning 2.0

Over recent months, the FDA has been focusing heavily on antibiotic safety, efficacy and clinical trials. Today, the New York Times reports that the FDA has asked an outside panel of experts to evaluate the safety of Ketek, a powerful antibiotic that has been linked to liver failure. The panel meeting will take place on December 14 and 15.

The FDA’s announcement comes after the Senate Finance Committee announced plans investigate how the agency handled the approval of the Sanofi-Aventis drug in 2004.

Regardless of the outcome of the panel’s investigation, it is clear that the FDA’s stance on antibiotics is changing. To learn more about this issue, please see the following posts on this blog:

- Antibiotics, Clinical Trials & More: An Interview With The FDA’s John Powers, MD

- Consumer Driven Healthcare: The Good, Bad and Money; FDA May Be Changing Tune On Antibiotic Trials

This entry was posted on November 15, 2006 at 10:13 am and is filed under FDA and the Pharmaceutical Industry. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.