Seriously ill patients who lack good treatments sometimes want to try a promising drug that is still under development. These patients often hope this drug will provide them with a lifeline where none had existed before.

Because of this need, FDA has had rules in place since 1987 that have allowed patients to have access to investigational drugs under certain circumstances, even though the safety and effectiveness of the drug has not been fully established.

The FDA recently announced changes to the rules to make them broader and clearer for the patient and the treating physician, while still preserving the integrity of clinical trials designed to find out whether a drug has a desired effect on some disease or condition.More »