Supplements Have Seen More Regulatory Burdens Than Standard Filings, Tufts Finds

NDA and BLA supplements have created more headaches for pharma companies than standard new drug or biologic applications, finds a new study from the Tufts Center for the Study of Drug Development. Those delays and other problems for supplemental drug filings hit their zenith during the early years of the Prescription Drug User fee Act (PDUFA) IV, in effect now and since fiscal 2008. Tufts’ survey of eight large pharma companies showed a 150-percent increase in complete response letters for sBLAs and sNDAs during 2008 to 2010, the early years of PDUFA IV, compared with 2005 to 2007 (within PDUFA III).
Drug Industry Daily