Around the Net

F.D.A. Institutes 18-Month Review On New Drugs

The Food and Drug Administration announced a new system yesterday to assess systematically a drug's safety 18 months after its introduction. The effort to ensure that marketed drugs are as safe as advertised is the latest effort to fix the agency after a series of missteps.

The agency also announced the creation of an advisory panel to improve the way it announces safety worries and a collaboration with the Veterans Health Administration to track how real patients fare after taking drugs.

Sen. Christopher J. Dodd, (D-Conn.), says that far greater changes are needed at the agency. Dodd promises to introduce two bills today that would reorganize the F.D.A. and require drug makers to disclose the results of all clinical trials involving humans.

F.D.A. commissioner Dr. Andrew C. von Eschenbach says the initiatives are "merely a step as we continue a process of improvement that will be ongoing."



Read the whole story at The New York Times »

Next story loading loading..