NORD Official: PDUFA VI 'Incredibly Impactful,' But Group Will Seek Amendments

The National Organization for Rare Disorders (NORD) commended the sixth drug user fee agreement, released July 15, for its potential benefits to the rare disease community, but a NORD official told Inside Health Policy that the group will work with lawmakers to offer amendments to the bill. In a press statement NORD highlighted the potential positive impact of PDUFA's expansion of FDA's Rare Diseases Program (RDP). Under PDUFA VI specialists from the rare disease program will be incorporated into...