BioCentury
ARTICLE | Politics & Policy

FDA identifies initial diseases for patient-focused initiative

April 11, 2013 11:33 PM UTC

FDA released a (see BioCentury, March 25).

FDA said it selected the list -- which includes breast cancer, female sexual dysfunction, lung cancer, pulmonary arterial hypertension (PAH), narcolepsy and sickle cell disease -- based on a set of selection criteria that included disease areas that reflect a range of severity, for which there are currently few or no therapies and areas and for which aspects of the disease aren't formally captured in clinical trials. FDA said it also considered the perspectives of the reviewing divisions at FDA and public comments on a list of 39 diseases that FDA released in September for which the agency said it lacks information to understand disease burden and current treatments as context for making benefit-risk assessments. ...