BioCentury
ARTICLE | Regulation

Following Katz at FDA

What industry, patients want from next FDA neurology division director

February 11, 2013 8:00 AM UTC

Senior biopharma executives and patient advocates hope the next director of FDA's Division of Neurology Products will have both the inclination to accept higher levels of regulatory uncertainty as the price for developing treatments for devastating diseases, and the stature to overcome inevitable opposition from within the agency and second-guessing from politicians and the media.

To make real progress against Alzheimer's and Parkinson's diseases, multiple sclerosis, epilepsy and other neurological diseases, drug developers and patient groups want FDA to approve drugs based on new endpoints, including some that haven't been as rigorously evaluated as has traditionally been required...