FDA unveils plan to eliminate orphan designation backlog

Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency ’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and resp onding to all new requests for designation within 90 days of receipt during his testimony before a Senate subcommittee.
Source: Food and Drug Administration - Category: American Health Source Type: news