Lawmakers Press FDA To Speed Up ALS Drugs, FDA Says Not So Easy

House lawmakers on Thursday (July 29) told FDA officials they aren’t moving fast enough to approve drugs that treat neurodegenerative diseases, namely amyotrophic lateral sclerosis, and they asked whether FDA needs authority to use a model similar to the Conditional Approval path Europe uses for some drugs. But drug center Director Patrizia Cavazzoni asserted FDA has plenty of tools to quickly review new drugs -- the real issue is lack of information about diseases like ALS. FDA can already expedite...