Risk Evaluation and Mitigation Strategy (REMS) for Certain Drugs and Biologics

September 5, 2008

The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS), the FDA said in a Federal Register notice published today.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA can require manufacturers to submit a REMS when a drug first comes on the market, or later if FDA becomes aware of new safety data about the drug. The manufacturers of the 25 drugs and biologic products identified in today’s notice must submit to the agency a proposed REMS by Sept. 21, 2008.

Effect

The user fees that will help support implementation of the Risk Minimization Action Plans … and the penalties, starting at $250,000 and potentially reaching $10 million, that can now be imposed for failure to adhere to drug safety provisions … are why it’s crucial for you to attend the Risk Management and Drug Safety Summit.

Source: FDA


Google Chrome (BETA) for Windows

September 5, 2008

Google Chrome is a browser that combines a minimal design with sophisticated technology to make the web faster, safer, and easier.

Features:

  1. One box for everything
    Type in the address bar and get suggestions for both search and web pages.
  2. Thumbnails of your top sites
    Access your favorite pages instantly with lightning speed from any new tab.
  3. Shortcuts for your apps
    Get desktop shortcuts to launch your favorite web applications.

Click here to Download Chrome (BETA) – the new browser from Google

Source: Google