FDA signals enhanced focus on patient input with new neurological guidances

FDA demonstrated its commitment to an enhanced focus on incorporating patient input into its drug review programs Thursday with the release of new guidance documents to help researchers approach development of drugs to treat neurological diseases.

In a statement, Commissioner Scott Gottlieb said FDA recognizes that given the uncertainty of the underlying causes of severe neurological diseases, progress in some therapeutic areas, like complex neurological diseases has been "uneven" compared to well understood ailments like cancer. In order to meet the urgent need for new treatments, FDA is "modernizing" its drug regulatory programs to become "more nimble, collaborative and patient-focused," Gottlieb wrote. ...