FDA May Change Handling of Safety Issues

Article in the Washington Post — FDA May Change Handling of Safety Issues, by the Associated Press:

The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.

As it does so, it plans to utilize data-mining techniques that could give the agency early warning of potential problems.

The FDA effort, being announced Thursday, parallels similar efforts under way to improve the agency’s response to drug safety concerns.

BGS